SARS-CoV-2 diagnostic pipeline
FIND is collating an overview of SARS-CoV-2 tests that are commercially available or in development for the diagnosis of COVID-19.
For immunoassays and molecular tests, we have compiled a fully searchable directory. Manufacturer performance data (sensitivity and specificity) are included, where known, alongside data from independent evaluations conducted by FIND, where applicable.
COVID-19 TEST DIRECTORY (Immunoassays, MOLECULAR tests)
We are continuing to build this database, and will be adding other tests as well as data from independent evaluations by other entities.
The list below was compiled from information submitted voluntarily by test suppliers and is not independently verified. If you have any queries or wish for us to make updates in the pipeline, please contact us.
To know more about the FIND evaluations of submitted SARS-CoV-2 tests, click here. ongoing test evaluations
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1126 Result(s)
- 1drop Inc. 1copy™ COVID-19 qPCR Multi Kit (Korea MFDS EUA - US FDA EUA - Health Canada - Saudi FDA - Sri Lanka NMRA - CE-IVD)
- 3B BlackBio Biotech India Ltd TRUPCR®SARS-CoV-2 RT qPCR Kit (India CDSCO - US FDA EUA)
- 3D Medicines 3DMed 2019-nCoV RT-qPCR Detection Kit (CE-IVD)
- 3D Medicines ANDiS® SARS-CoV-2 RT-qPCR Detection Kit (US FDA EUA - CE-IVD)
- A*ccelerate Technology A*STAR Fortitude Kit 2.0 (Singapore HSA)
- AAZ-LMB COVID-PRESTO® (CE-IVD)
- AB ANALITICA srl REALQUALITY RQ-2019-nCoV (CE-IVD)
- AB ANALITICA srl REALQUALITY RQ-SARS-CoV-2 (CE-IVD)
- AB Dianostic Systems GmbH abia SARS-CoV-2 IgG/IgM (CE-IVD)
- Abace Biotechnology Virus Sampling Kit (CE-IVD)
- Abace Biotechnology COVID-19 IgG / IgM Antibody Test Kit (CE-IVD)
- Abacus Diagnostica GenomEra SARS-CoV-2 Assay Kit (CE-IVD)
- Abbott Diagnostics Panbio™ COVID-19 Ag Rapid Test Device (Australia TGA - South Africa SAHPRA - WHO EUL)
- Abbott Diagnostics Panbio™ COVID-19 IgG/IgM Rapid Test Device (CE-IVD)
- Abbott Diagnostics Inc. ID NOW COVID-19 (US FDA EUA )
- Abbott Diagnostics Scarborough, Inc BinaxNOW COVID-19 Ag Card (US FDA EUA)
- Abbott Laboratories AdviseDx SARS-CoV-2 IgM (US FDA EUA)
- Abbott Laboratories SARS-CoV-2 IgM Kit (Australia TGA)
- Abbott Laboratories Abbott Architect SARS-CoV-2 IgG (US FDA EUA - Singapore HSA - Health Canada - CE-IVD)
- Abbott Laboratories NAVICA™ Mobile App and BINAXNOW™ COVID-19 Ag Card (US FDA EUA)
- Abbott Molecular Inc. Alinity m SARS-CoV-2 (US FDA EUA - Singapore HSA - Australia TGA - CE-IVD)
- Abbott Molecular Inc. Abbott RealTime SARS-CoV-2 EUA test (US FDA EUA - Australia TGA - Brazil ANVISA - Health Canada - Singapore HSA - South Africa SAHPRA - CE-IVD - WHO EUL)
- Absea Biotechnology Ltd The non-invasive MEGA test of SARS-CoV-2 (mucosal swabs) (In development)
- Abwiz Bio RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA) (In development)
- Academia Sinica Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit (In development)
- Accelerate Technology Pte Ltd Resolute 2.0 assay (Singapore HSA)
- Access Bio Inc. CareStart™ COVID-19 Antigen (Australia TGA - US FDA EUA)
- Access Bio, Inc. CareStart™ COVID-19 MDx RT-PCR (US FDA EUA - CE-IVD)
- Access Bio, Inc. CareStart™ COVID-19 IgM/IgG (US FDA EUA - RUO)
- AccuBioTech Co. Ltd Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette (CE-IVD)
- Accuster Technologies Pvt Ltd Accuster SARS-COV2-RT-PCR test kit (CE-IVD)
- Accuster Technologies Pvt Ltd COVID-19 RAPID IgG/IgM test kit (CE-IVD)
- Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test (CE-IVD)
- Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 Antigen Rapid Test (CE-IVD)
- Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 Antigen FIA (CE-IVD)
- Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 RT-PCR Test Kit (CE-IVD)
- ACON Laboratories, Inc. Flowflex™ SARS-CoV-2 Antigen Rapid Test (CE-IVD)
- ACON Laboratories, Inc. SARS-CoV-2 RT-PCR Test Kit (CE-IVD)
- ACON Laboratories, Inc. ACON® COVID-19 IgG/IgM Rapid Test (US FDA EUA - CE-IVD)
- ACRO BIOTECH Inc. COVID-19 and Influenza A+B Antigen Combo Rapid Test (CE-IVD)
- ACRO BIOTECH Inc. SARS-COV-2 RT-qPCR Assay (Brazil ANVISA - CE-IVD)
- ACRO BIOTECH Inc. COVID-19 Antigen Rapid Test (Oral Fluid) (CE-IVD)
- ACRO BIOTECH Inc. COVID-19 Antigen Test Cassette (FIA) (CE-IVD)
- ACRO BIOTECH Inc. Família Teste Rápido em Cassete 2019-nCoV IgG/IgM (Brazil ANVISA)
- ACRO BIOTECH Inc. 2019-nCoV IgG/IgM Rapid Test (Brazil ANVISA - CE-IVD)
- ACRO BIOTECH Inc. COVID-19 Antigen Rapid Test with Reader (CE-IVD)
- ACRO BIOTECH Inc. COVID-19 and Influenza A+B Antigen Combo Rapid Test with Reader (CE-IVD)
- ACRO BIOTECH Inc. COVID-19 Antigen Rapid Test (Brazil ANVISA - CE-IVD)
- Actim Oy Actim SARS CoV-2 IgG/IgM (In development)
- Actim Oy Actim SARS CoV-2 (In development)
- Actim Oy Actim ELISA SARS CoV-2 IgG/IgM (In development)
- Actim Oy Actim ELISA SARS CoV-2 IgG (CE-IVD)
- Acumen Research Laboratories Pte Ltd Acu-Corona (RUO)
- Acumen Research Laboratories Pte Ltd Acu-Corona 2.0 (Singapore HSA)
- Adaltis S.r.l. MOLgen SARSCoV2 Real Time RT PCR (CE-IVD)
- ADT Biotech LyteStar 2019-nCoV RT-PCR Kit 1.0 (RUO)
- Advagen Biotech Ltd COVID-19 IgG/IgM LF (Brazil ANVISA)
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Advanced Biological Laboratories SA
DeepChek® 8-Plex CoV-2 Genotyping Assay (by NGS) (RUO)
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Advanced Biological Laboratories SA
UltraGene Assay SARS-CoV-2 N / Spike Δ 69-70 V1 (RUO)
- Advanced Biological Laboratories SA UltraGene Combo2Screen SARS-CoV-2 Assay (South Africa SAHPRA - CE-IVD)
- Advanced Molecular Diagnostics Zena Max – SARS-COV-2 Real Time PCR Detection Kit (CE-IVD)
- Advanced Molecular Diagnostics Zena Max – SARS-COV-2 Direct q-PCR Detection Kit (CE-IVD)
- Adversis Pharma GmbH AProof SARS CoV-2 IgG ELISA (CE-IVD)
- AffinityImmuno Inc. SARS-CoV-2 Neutralizing Antibody Test Kit (RUO)
- Agena Bioscience iPLEX Pro SARS-CoV-2 Panel (CE-IVD - RUO)
- AITbiotech abTES COVID-19 qPCR I Kit (Singapore HSA - South Africa SAHPRA - CE-IVD)
- AIVD Biotech Inc. SARS-CoV-2 OFR1ab/N/E Triple Nucleic Acid Detection Kit (RT-qPCR) (RUO)
- AIVD Biotech Inc. SARS-CoV-2 OFR1ab / N Dual Nucleic Acid Detection Kit (RT-qPCR) (RUO)
- AIVD Biotech Inc. SARS-CoV-2 Antigen Detection Rapid Lateral Flow Test (RUO)
- AIVD Biotech Inc. SARS-CoV-2 OFR1ab / N (contains endogenous genes) Triple Nucleic Acid Detection Kit (RT-qPCR) (RUO)
- AIVD Biotech Inc. COVID-19 IgG/IgM Rapid Test (colloidal gold-based) (In development)
- AIVD Biotech Inc. SARS-CoV-2 OFR1ab / N/E gene (contains endogenous genes) Fourfold Nucleic Acid Detection Kit (RT-qPCR) (RUO)
- Alcotech Pte Ltd 2019-nCoV IgG/IgM Rapid Test Cassette (Singapore HSA)
- Aldatu Biosciences PANDAA qDx SARS-CoV-2 (RUO)
- Alfa Scientific Designs, Inc. Instant-view Plus Covid-19 Antigen Test (RUO)
- Alfa Scientific Designs, Inc. Instant-view Plus Covid-19 Antibody Test (CE-IVD)
- AlphaBiolabs Coronavirus test kit - sample collection (CE-IVD)
- altona Diagnostics RealStar® SARS-CoV-2 RT-PCR Kit 1.0 (US FDA EUA - CE-IVD)
- AMEDA Labordiagnostik GmbH AMP ELISA Test SARS-CoV-2 Ab (CE-IVD)
- AMEDA Labordiagnostik GmbH AMP ELISA Test SARS-CoV-2 IgG (CE-IVD)
- AMEDA Labordiagnostik GmbH AMP ELISA Test SARS-CoV-2 IgM (CE-IVD)
- AMEDA Labordiagnostik GmbH AMP Rapid Test SARS-CoV-2 Ag (CE-IVD)
- AMEDA Labordiagnostik GmbH AMP Rapid Test SARS-CoV-2 IgG/IgM (CE-IVD)
- AmonMed Biotechnology Co., Ltd COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)
- AmonMed Biotechnology Co., Ltd COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)
- AmonMed Biotechnology Co., Ltd COVID-19/Influenza A virus/Influenza B virus IgM combo test kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)
- AmonMed Biotechnology Co., Ltd COVID-19 IgM/IgG test kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)
- AmonMed Biotechnology Co., Ltd COVID-19 IgM/IgG test kit (Colloidal Gold) (CE-IVD)
- Amoy Diagnostics Co., Ltd AmoyDx® Novel Coronavirus (2019 nCoV) Detection Kit (CE-IVD)
- Amplicon Ltd AmpliTest SARS-CoV-2 (Real Time PCR) (CE-IVD)
- AmpliGene India Biotech Pvt. Ltd AmpEZ Rapid and sensitive Real time COVID-2019 test (RUO)
- AMS UK Ltd COVID-19 ELISA (total antibody) (CE-IVD)
- AMS UK Ltd COVID-19 IgG ELISA (CE-IVD)
- AMS UK Ltd COVID-19 IgM ELISA (CE-IVD)
- AMS UK Ltd COVID-19 Antigen ELISA (CE-IVD)
- AMS UK Ltd 2019-nCoV IgG/IgM Device (CE-IVD)
- AMS UK Ltd COVID-19 Lyophilised Nucleic Acid Kit (CE-IVD)
- Anatolia Geneworks Bosphore Novel Coronavirus (2019-nCoV) Detection Kit (lab-based) (CE-IVD)
- Anbio (Xiamen) Biotechnology Co., Ltd COVID-19 Hybrid Capture Fluorescence Immunoassay Test (China NMPA EUA)
- Anhui Anlong Gene Technology Co., Ltd Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR) (CE-IVD)
- Anhui Deepblue Medical Technology Co., Ltd Colloidal gold strip for SARS-CoV-2 IgG & IgM (RUO)
- Anhui Deepblue Medical Technology Co., Ltd COVID-19 Neutralizing Antibody Test Kit (Colloidal Gold) (RUO)
- Anhui Deepblue Medical Technology Co., Ltd COVID-19 Antibody & Antigen Combo Test Kit (Colloidal Gold) (CE-IVD)
- Anhui Deepblue Medical Technology Co., Ltd COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) (CE-IVD)
- Anhui Deepblue Medical Technology Co., Ltd COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)--Saliva (CE-IVD)
- Anhui Deepblue Medical Technology Co., Ltd Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) (CE-IVD)
- Anhui Deepblue Medical Technology Co., Ltd COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (CE-IVD)
- Anlongen nConV-19 Nucleic Acid qPCR Kit (China NMPA EUA - CE-IVD)
- Anomalous Materials Pte Ltd 2019-nCoV IgG/IgM Rapid Testing Kit (CE-IVD)
- Ansh Labs SARS-CoV2 IgG ELISA (CE-IVD)
- Ansh Labs SARS-CoV2 IgM ELISA (CE-IVD)
- AnyGenes Efficient 2019-nCOV detection kit, one step RT-qPCR (N1 & N2) (RUO)
- Apollo Biomedical LLC Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) (MHRA UK - CE-IVD)
- Apollo Biomedical LLC Novel SARS-CoV-2 Coronavirus/MERS-CoV/Influenza Virus A/B Multiple Antigen Detection Kit (RUO)
- Applied BioCode Inc. BioCode SARS-CoV-2 Assay (US FDA EUA)
- Applied Biological Materials Inc. GenomeCoV19 Detection Kit (CE-IVD)
- Applied Biological Materials Inc. GenomeCov19 IgM/IgG Rapid Test Kit (CE-IVD)
- Applied Biological Materials Inc. Sample Collection and Viral Transport Solution (CE-IVD)
- Applied Biomedical, LLC Confidence COVID-19 Rapid Test (RUO)
- Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit (US FDA EUA)
- Appolon Bioteck Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) (China NMPA EUA - CE-IVD)
- Aptamer Group Ltd ADx SARS Co V-2 Virus Antigen Rapid Point of Care Test (In development)
- ArcDia International Ltd mariPOC SARS-CoV-2 (CE-IVD)
- Ardent Biomed Guangdong Inc. Ardent Throat Swab Sampling Kit for SARS-CoV-2 (US FDA EUA - CE-IVD)
- Artron Laboratories Inc. Artron COVID-19 IgM/IgG Test Kit (Brazil ANVISA)
- Artron Laboratories Inc. Artron COVID-19 Antigen Test Kit (CE-IVD)
- Asan Pharmaceutical Co. Ltd Asan Easy Teste Covid-19 IgG/IgM (Brazil ANVISA)
- Assure Tech. (Hangzhou) Co., Ltd COVID-19 Antigen Rapid Test Device (CE-IVD)
- Assure Tech. (Hangzhou) Co., Ltd COVID-19 IgG/IgM Rapid Test Device (Brazil ANVISA - US FDA EUA - CE-IVD)
- Atila BioSystems, Inc. Atila iAMP COVID-2019 Detection Kit (US FDA EUA - South Africa SAHPRA)
- Ativa Medical Ativa Enhanced Screen (In development)
- Atlas Medical Atlas COVID-19 IgM Elisa Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 Total Antibody Elisa Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 S1-RBD IgG Elisa Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 Real Time RT-PCR Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 IgG/IgM Test Cassette (CE-IVD)
- Atlas-Link (Beijing) Technology Co. Ltd Covid-19 IgM/IgG Antibody Test (Colloidal Gold) (Australia TGA - CE-IVD)
- Atlas-Link (Beijing) Technology Co. Ltd SARS-COV-2 Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)
- Atlas-Link (Beijing) Technology Co. Ltd NOVA Test ® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) (CE-IVD)
- Atlaslink Beijing Technology Co., Ltd NOVA Test® COVID-19 IgG/IgM Antibody Test (Colloidal Gold) (Australia TGA)
- Attomarker Ltd Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP (automated) (MHRA UK)
- Augurix SA Simtomax Corona Check IgM/IgG Rapid COVID 19 test (CE-IVD)
- Augurix SA Simtomax CoronaCheck Antigen (CE-IVD)
- Aura Biotechnologies Ltd Quick COVID-19 Colorimetric LAMP PCR (In development)
- Aura Biotechnologies Ltd Quick COVID-19 Realtime Multiplex PCR (In development)
- Aurora Biomed Inc. SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation (In development)
- AusDiagnostics SARS-CoV-2, Influenza and RSV 8-well (Australia TGA - RUO)
- Autobio Diagnostics Co., Ltd Anti-SARS-CoV-2 (China NMPA EUA - US FDA EUA - Brazil ANVISA - CE-IVD)
- Avacta Life Sciences Ltd AffiDX® SARS-CoV-2 Lateral Flow Antigen Test (In development)
- Avioq Bio-Tech Co., Ltd Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold) (Brazil ANVISA - RUO)
- Axium Bioresearch Inc. AxiumHealth COVID-19 IgG/IgM Antibody Test (RUO)
- BAG Diagnostics GmbH ViroQ Rapid SARS-CoV-2 (CE-IVD)
- BAG Diagnostics GmbH ViroQ SARS-CoV-2 (CE-IVD)
- BAG Diagnostics GmbH ViroQ SARS-FluA/B-RSV (CE-IVD)
- Bai-care (Tianjin) Biotechnology Co., Ltd Multiplex Nucleic Acid Detection Kit for Respiratory Pathogens (CE-IVD)
- Baiya Phytopharm, Co, Ltd Baiya Rapid COVID-19 IgM/IgG test kit (In development)
- Bao Ruiyuan Biotech (Beijing) Co., Ltd. Novel Coronavivus(2019-nCov)Nucleic Acid Detection Kit-Multiple Fluorescence PCR (RUO)
- BD BioGX SARS-CoV-2 Reagents for BD MAX™ System (US FDA EUA - Health Canada - Australia TGA - Brazil ANVISA - Singapore HSA)
- Beckman Coulter Inc. Access SARS-CoV-2 IgG (US FDA EUA - Singapore HSA - Brazil ANVISA - Australia TGA)
- Becton Dickinson & Company BD Veritor System for Rapid Detection of SARS-CoV-2 (Australia TGA - Health Canada - US FDA EUA )
- Beijing Abace Biology Co., Ltd COVID-19 IgM Antibody Test Kit (ELISA) (CE-IVD)
- Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) (CE-IVD)
- Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (ELISA) (CE-IVD)
- Beijing Abace Biology Co., Ltd COVID-19 Antibody (IgG/IgM)Test Kit (Colloidal Gold Immunochromatography) (India CDSCO - CE-IVD)
- Beijing Abace Biology Co., Ltd COVID-19 IgG Antibody Test Kit (ELISA) (CE-IVD)
- Beijing Applied Biological Technologies Co., Ltd Multiple Real-Time PCR Kit for Detection of 2019-nCoV (China NMPA EUA - CE-IVD - WHO EUL)
- Beijing Beier Bioengineering Co., Ltd Multiple Real-time PCR kit for Detection of SARS-CoV-2 RNA (In development)
- Beijing Biochem Hengye Science & Technology Development Co., Ltd SARS-CoV-2 Real-Time RT-PCR Kit (RUO)
- Beijing Biogench Biotechnology Co., Ltd Diagnostic Kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) (CE-IVD)
- Beijing Bohui Innovation Biotechnology Automated SarS-CoV-2 NAT (RUO)
- Beijing Bohui Innovation Biotechnology Fully Automated 26 Plex RES Panel Assay (RUO)
- Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgG Antibody Determination Kit (CE-IVD)
- Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgG/IgM Antibody Rapid Test Kit (colloidal gold assay) (CE-IVD)
- Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgM Antibody Determination Kit (CE-IVD)
- Beijing Diagreat Biotechnologies Co., Ltd Time-Resolved Immunofluorescence Analyzer (CE-IVD)
- Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) (CE-IVD)
- Beijing Genskey Medical Technology Co., Ltd SARS-CoV-2 Nucleic Acid Detection Kit (RT-qPCR with Taqman-Probe) (RUO)
- Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) IgM/IgG Antibody Rapid Test (Colloidal Gold) (CE-IVD)
- Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Enzyme-Linked Immunosorbent Assay) (CE-IVD)
- Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Colloidal Gold) (CE-IVD)
- Beijing Hotgen Biotech Co., Ltd Coronavirus disease(COVID-19) Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) (CE-IVD)
- Beijing Hotgen Biotech Co., Ltd Coronavirus disease (COVID-19) Antibody Test (Up-converting Phosphor Technology) (CE-IVD)
- Beijing Infervision Technology Co. Ltd InferRead CT Pneumonia (In development)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Nucleic Acid Test Kit (CE-IVD)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG ELISA Test Kit (CE-IVD)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) (CE-IVD)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (CE-IVD)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgM ELISA Test Kit (CE-IVD)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Fluorescence) (CE-IVD)
- Beijing Kinhawk Pharmaceutical Co., Ltd 2019-nCoV ORF1ab/N Gene Detection Kit (Fluorescence PCR Method) (RUO)
- Beijing Lepu Medical Technology Co., Ltd 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) (CE-IVD)
- Beijing Lepu Medical Technology Co., Ltd SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) (Brazil ANVISA - CE-IVD)
- Beijing Microread Genetics Co.,Ltd COVID-19 (SARS-CoV-2) Detection Kit (LAMP) - lab-based or near-POC (CE-IVD)
- Beijing NaGene Diagnosis Reagent Co., Ltd Multiple Real-Time PCR kit for Detection of 2019-nCoV (China NMPA EUA - CE-IVD)
- Beijing Savant Biotechnology Co., Ltd New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunochromatography) (Singapore HSA - CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Antigen Rapid Test (CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) (India CDSCO - CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Antigen Rapid Test (FIA) (CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Antigen Saliva Rapid Test (CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun Flu A/B, COVID-19 Ag Combo test (CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun Flu A/B, RSV, COVID-19 Ag Combo test (CE-IVD)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 Ab Rapid Test (Australia TGA - US FDA EUA - CE-IVD)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 Antigen Rapid Test (Colloidal gold) (CE-IVD)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 IgM ELISA (CE-IVD)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 IgG ELISA (CE-IVD)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 Ab ELISA (Australia TGA - US FDA EUA - CE-IVD)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 RT-PCR Kit (US FDA EUA - CE-IVD - WHO EUL)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 Ag ELISA (CE-IVD)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-COV-2 Antigen Rapid Test (FIA) (CE-IVD)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 IgG Rapid Test (Semi-Quantitative) (CE-IVD)
- BGI Health Co. Ltd SARS-CoV-2 Virus IgG Antibody Detection Kit (ELISA) (CE-IVD)
- BGI Health Co. Ltd SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold) (CE-IVD)
- BGI Health Co. Ltd Real-time fluorescent RT-PCR kit for detecting 2019 nCoV (US FDA EUA - Australia TGA - China NMPA EUA - Health Canada - Singapore HSA - South Africa SAHPRA - CE-IVD - WHO EUL)
- BGI Health Co. Ltd SARS-CoV-2 Virus IgM Antibody Detection Kit (ELISA) (CE-IVD)
- Bio Basic Canada Inc. SARS-CoV-2 RT-PCR Detection Kit (CE-IVD)
- Bio-Diagnostics Ltd Covid-19 Immunity Biocard™ Spike Antibody Test (CE-IVD)
- Bio-Rad Laboratories Inc. Platelia SARS-CoV-2 Total Ab (US FDA EUA - Australia TGA - Singapore HSA - CE-IVD)
- Bio-Rad Laboratories, Inc. Bio-Rad SARS CoV-2 ddPCR Assay (US FDA EUA - Philippines FDA - RUO)
- Bio-Techne Ella / Simple Plex COVID-19 16×4 Standard Panel (RUO)
- biocan diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test (US FDA EUA - CE-IVD)
- biocan diagnostics Inc. Tell Me Fast COVID19 Antigen Test (CE-IVD)
- BioCore Co., Ltd BioCore 2019-nCoV Real Time PCR Kit (US FDA EUA)
- Bioeksen R&D Technologies Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit (CE-IVD)
- BioFire Defense, LLC BioFire COVID-19 Test (US FDA EUA - Health Canada - Singapore HSA - South Africa SAHPRA)
- BioFire Diagnostics Inc. BioFire Respiratory Panel 2.1 (RP2.1) (US FDA EUA - Health Canada - South Africa SAHPRA - Philippines FDA)
- Biogate Laboratories Ltd COVID-19 IgG/IgM Ab Rapid Test (RUO)
- BioGenex Laboratories BGX COVID-19 RT-PCR™ (one-step multiplex real time RT-PCR) (US FDA EUA)
- Biogenix Inc. Pvt Ltd. SARS CoV-2 IgG/IgM Ab Rapid Test (RUO)
- BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) (US FDA EUA - Australia TGA - CE-IVD)
- BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 Antigen quantitative assay kit (Enzyme-linked immunoassay) (Australia TGA - Brazil ANVISA - CE-IVD)
- BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) (CE-IVD)
- BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 Antigen assay kit (Colloidal Gold Method) (In development)
- BioLab Sciences COVID-19 Rapid IgM/IgG Antibody Test Kit (RUO)
- Biolidics Ltd ClearEpi™ SARS-CoV-2 Antigen Rapid Test (CE-IVD)
- Biolidics Ltd 2019-nCoV IgG/IgM Antibody Detection Kit (Singapore HSA - CE-IVD)
- bioLytical Laboratories Inc. INSTI COVID-19 Antibody Test (CE-IVD)
- bioLytical Laboratories Inc. INSTI COVID-19 Self Test (RUO)
- BioMaxima S.A. COVID-19 Antigen Rapid Test (CE-IVD)
- BioMaxima S.A. SARS-CoV-2 Real Time PCR LAB-KIT™ (CE-IVD)
- BioMaxima S.A. 2019-nCoV IgG/IgM Rapid Test Cassette (India CDSCO - CE-IVD)
- BioMedomics, Inc. COVID-19 IgM-IgG Dual Antibody Rapid Test (India CDSCO - CE-IVD)
- Biomeme COVID-19 Go Strips (US FDA EUA - Health Canada)
- bioMérieux SA SARS-COV-2 R-GENE® (ref 423735) (US FDA EUA - South Africa SAHPRA - Philippines FDA - Brazil ANVISA)
- bioMérieux SA VIDAS SARS-CoV-2 IgG & IgM (US FDA EUA - Philippines FDA)
- bioMérieux SA SARS-COV-2 R-GENE® (ref 423720) (CE-IVD)
- bioMérieux SA SARS-COV-2 R-GENE® (ref 423717) (RUO)
- BIONEER Corporation AccuPower® SARS-CoV-2 Real-Time RT-PCR kit (manual kit: SCV-2122) (Philippines FDA - CE-IVD)
- BIONEER Corporation AccuPower® COVID-19 Real-Time RT-PCR kit (lab-based automated kit: NCV-1111) (CE-IVD)
- Bioneer Inc., part of BIONEER Corp. SCVR-2122 AccuPower®SARS-CoV-2 Real-Time RT-PCR Kit (50 tests) (RUO)
- Bionote Inc. NowCheck COVID-19 Ag Test (Korea export - CE-IVD)
- Bionote Inc. NowCheck COVID-19 IgM/IgG Test (Australia TGA - Korea export - CE-IVD)
- BIORON Diagnostics GmbH RealLine SARS-CoV-2 (different formats) (CE-IVD)
- BIORON Diagnostics GmbH RealLine SARS-CoV-2 lyo (Str-format) (CE-IVD)
- BioSewoom, Inc. Real-Q 2019-nCoV Detection Kit (US FDA EUA - Korea MFDS EUA - CE-IVD)
- Biosino Bio-Technology and Science Inc SARS-COV-2 Antibody Test (CE-IVD)
- BioSpeedia COVID19Speed-Antigen (CE-IVD)
- BioSpeedia COVID19SEROSpeed-IgM-IgG (CE-IVD)
- Bioss Inc. SARS-Cov-2 IgM Antibody ELISA Kit (RUO)
- Bioss Inc. SARS-Cov-2 Nucleoprotein ELISA Kit (RUO)
- Bioss Inc. SARS-Cov-2 Total Antibody ELISA Kit (RUO)
- BIOSYNEX SWISS SA BIOSYNEX COVID-19 BSS (Brazil ANVISA - Singapore HSA - CE-IVD)
- BIOSYNEX SWISS SA BIOSYNEX COVID-19 Ag BSS (CE-IVD)
- Biotech & Biomedicine (Shenyang) Group Ltd Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus (CE-IVD)
- Biotech & Biomedicine (Shenyang) Group Ltd Real Time PCR Detection Kit For COVID-19 Coronavirus (CE-IVD)
- BIOTECON Diagnostics GmbH microproof SARS-CoV-2 Screening/Identification Kits (RUO)
- BIOTECON Diagnostics GmbH Acu-CoronaTM 2.0/3.0 SARS-CoV-2 Real-time PCR Kits (Philippines FDA - RUO)
- BIOTECON Diagnostics GmbH virusproof SL SARS-CoV-2 Real-time PCR Kit (RUO)
- Biotical Health biotical SARS-CoV-2 Ag card test (CE-IVD)
- BioTNS Co. Ltd COVID-19 RT-PCR PNA KIT (US FDA EUA - Korea MFDS EUA - Philippines FDA - CE-IVD)
- Biotrack BTMED COV19 (CE-IVD)
- Blue Cross Bio-Medical (Beijing) Co., Ltd One Step Novel Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (CE-IVD)
- Blue Cross Bio-Medical (Beijing) Co., Ltd COVID-19 Antigen Test (CE-IVD)
- BluSense Diagnostics ApS ViroTrack COVID IgA+IgM/IgG/Total Ig Ab (CE-IVD)
- Boditech Inc. AFIAS COVID-19 Ab, IgM/IgG (automated) (Brazil ANVISA - CE-IVD)
- Boditech Inc. Ichromia COVID-19 Ab, IgM/IgG (manual) (Brazil ANVISA - CE-IVD)
- Boditech Inc. NuActor – viral RNA extraction kit (Korea MFDS EUA - CE-IVD)
- Boditech Inc. Ichroma COVID-19, viral antigen (manual) (RUO)
- Boditech Inc. ExAmplar COVID-19 real-time PCR kit (L) (RUO)
- Boditech Inc. AFIAS COVID-19, Viral Antigen (automated) (Philippines FDA - Brazil ANVISA - CE-IVD)
- Bosch Healthcare Solutions GmbH Vivalytic SARS-CoV-2 Pooling (CE-IVD)
- Bosch Healthcare Solutions GmbH Vivalytic SARS-CoV-2 (CE-IVD)
- Bosch Healthcare Solutions GmbH Vivalytic CoV (CE-IVD)
- Bright Line Research Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test (In development)
- BTNX Inc. Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)
- BTS Consultores S.A.C. CavBio RT-PCR COVID-19 kit V1.0 (In development)
- Calbiotech, Inc. ErbaLisa COVID-19 IgG ELISA (US FDA EUA - Brazil ANVISA - CE-IVD)
- Calbiotech, Inc. ErbaLisa COVID-19 IgM ELISA (RUO)
- Camtech Diagnostics Pte Ltd Camtech COVID-19 Rapid Test Kit (Singapore HSA - CE-IVD)
- Canary Health Technologies AiroStotleCV19 (Breath VOCs) (In development)
- Cancer Rop Co., Ltd. Q-Sens® 2019-nCoV Detection Kit (CE-IVD)
- Canvax Biotech qMAXSentm Coronavirus (SARS-CoV-2) RT-qPCR Detection Kit (RUO)
- CapitalBio Technology Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) (China NMPA EUA)
- Caspr Biotech Lyo-CRISPR SARS-CoV-2 Kit (In development)
- Caspr Biotech Phantom 1.0 Dx (near-POC) (In development)
- Cell ID Pte Ltd Smart COVID-19 IgM/IgG RDT (CE-IVD)
- Cellbae Pte. Ltd TEPAT 1.0 SARS-CoV-2 Multiplex RT-PCR (Singapore HSA - CE-IVD)
- Cellex Inc. Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test (US FDA EUA - Australia TGA - Brazil ANVISA - CE-IVD)
- CellMade CellInsight SARS-CoV-2 Detection Kit (CE-IVD)
- CellSafe LAMPlex RT-qLAMP COVID-19 Detection Assay (Fast Detection) (Korea MFDS EUA SFDA, Malaysia - Malaysia MDA - CE-IVD)
- Cepheid Xpert Xpress SARS-CoV-2 (US FDA EUA - Health Canada - Australia TGA - Singapore HSA - South Africa SAHPRA - Philippines FDA - CE-IVD - WHO EUL)
- CerTest Biotec S.L. CerTest SARS-CoV-2 (CE-IVD)
- CerTest Biotec, S.L. VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit adapted for BD MAX™ System (CE-IVD)
- CerTest Biotec, S.L. VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit (Australia TGA - Brazil ANVISA - South Africa SAHPRA - CE-IVD)
- CerTest Biotec, S.L. VIASURE SARS-CoV-2 Real Time PCR Detection Kit (CE-IVD)
- Changsha Sinocare Inc. SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method) (CE-IVD)
- Chaozhou Hybribio Biochemistry Ltd COVID-19 Real-Time PCR Kit (manual & automated lab-based) (Brazil ANVISA - CE-IVD - WHO EUL)
- Chengdu Fengji Biotechnology Co., Ltd of China 2019-nCoV Nucleic acid detection kit (multiplex PCR fluorescent probe method) (China NMPA EUA)
- Chil Tibbi Mal. San. Tic. Ltd Sti. Chil COVID-19 IgG/IgM (whole blood/serum/plasma) Rapid Test (CE-IVD)
- ChromaCode, Inc. ChromaCode COVID-19 Six Target Single Well Assay (US FDA EUA - RUO)
- Clear Labs Inc. Clear Dx SARS-CoV-2 Test (US FDA EUA)
- Clonit quanty-CONV-19 (CE-IVD)
- Co-diagnostics Logix Smart™ Coronavirus Disease 2019 (COVID-19) Kit (US FDA EUA - South Africa SAHPRA - CE-IVD)
- Confirm BioSciences Verasure™ COVID-19 Antigen Rapid Swab Test (RUO)
- Confirm BioSciences Verasure™ Coronavirus (Covid19) IgG & IgM Test (RUO)
- Core Technology Co., Ltd COVID-19 IgM/IgG Ab Test (South Africa SAHPRA - CE-IVD)
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Coris BioConcept
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(validated ICMR)
- Coyote Bioscience Co., Ltd DirectDetect™ SARS-CoV-2 Detection Kit (Australia TGA - China NMPA EUA - CE-IVD)
- Creative Biolabs SARS-CoV-2 (2019-nCoV) Nucleoprotein Protein ELISA Kit (RUO)
- Creative Biolabs SARS-CoV-2 (2019-nCoV) Anti-NP IgG ELISA Kit (RUO)
- Creative Biolabs SARS-CoV-2 (2019-nCoV) Anti-S1 RBD IgG ELISA Kit (RUO)
- Creative Biolabs SARS-CoV-2 (2019-nCoV) N qRT-PCR (Taqman™) Detection Kit (RUO)
- Creative Biolabs SARS-CoV-2 (2019-nCoV) Multiplex qRT-PCR Detection Kit (RUO)
- Creative Biolabs SARS-CoV-2 (2019-nCoV) Spike Protein ELISA Kit (RUO)
- Creative Biolabs SARS-CoV-2 (2019-nCoV) Total Antibody Rapid Test Kit (RUO)
- Creative Diagnostics SARS-COV-2 Total Antibody ELISA Kit (RUO)
- Creative Diagnostics SARS-CoV-2 IgM ELISA Kit (RUO)
- Creative Diagnostics SARS-CoV-2 Antigen ELISA Kit (RUO)
- Creative Diagnostics SARS-CoV-2 IgG ELISA Kit (RUO)
- Credo Diagnostics Biomedical VitaPCR COVID-19 assay (Singapore HSA)
- CTK Biotech, Inc. Aridia COVID-19 Real Time PCR Test (Australia TGA - Philippines FDA - CE-IVD)
- CTK Biotech, Inc. OnSite™ COVID-19 IgG/IgM (Australia TGA - Brazil ANVISA - India CDSCO)
- Curative Inc. (in conjunction with KorvaLabs, Inc.) Curative-Korva SARS-Cov-2 Assay (US FDA EUA)
- Cytecs GmbH SARS-CoV-2 RT-PCR (CE-IVD)
- DAAN Gene Co., Ltd of Sun Yat-sen University Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit (China NMPA EUA - CE-IVD - WHO EUL)
- DART Diagnostics DART COVID-19 (manual) (In development)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgA ELISA (CE-IVD)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgG ELISA (CE-IVD)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgM ELISA (CE-IVD)
- Denka Co. Ltd QuickNavi-COVID19 Ag (Japan MHLW IVD)
- Denovo Biolabs Pvt Ltd DeQuanto SARS CoV-2 RTqPCR Kit (In development)
- Dermoaroma Italy Srl D-Biotech: Real-time RT-PCR Detection Kit for COVID-19 (CE-IVD)
- DIA.PRO Diagnostic Bioprobes Srl COV19CONF.CE - ELISA COVID 19 IgG Confirmatory (CE-IVD)
- DIA.PRO Diagnostic Bioprobes srl COVID-19 RNA Vs 2 (CE-IVD)
- DIA.PRO Diagnostic BioProbes Srl COV19G.CE - ELISA COVID 19 IgG (CE-IVD)
- DIA.PRO Diagnostic Bioprobes srl ACE2-RBD Neutralization Assay (CE-IVD)
- DIA.PRO Diagnostic BioProbes Srl COV19M.CE - ELISA COVID 19 IgM (CE-IVD)
- Diagen Biotechnologic Systems Inc. SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-gene) OneStep R (CE-IVD)
- Diagnostics for the Real World Ltd SAMBA II COVID-19 Test (near-POC NAT) (CE-IVD)
- DIALAB GmbH DIAQUICK COVID-19 Ag Test (CE-IVD)
- DiaSorin Molecular, LLC Simplexa™ COVID-19 Direct RT-PCR Kit (US FDA EUA - CE-IVD - WHO EUL)
- DiaSorin SpA LIAISON®SARS-CoV-2 AG (CE-IVD)
- DiaSorin SpA LIAISON®SARS-CoV-2 S1/S2 IgG (US FDA EUA - Health Canada - Brazil ANVISA - CE-IVD)
- Diatech Pharmacogenetics Easy® SARS-CoV-2 (CE-IVD)
- Diatech Pharmacogenetics EasyPGX® ready SARS-CoV-2 (CE-IVD)
- Diatheva SRL COVID-19 PCR DIATHEVA Detection kit (CE-IVD)
- Diesse Diagnostica Senese SpA ELISA Enzywell SARS-CoV-2 IgG (CE-IVD)
- Diesse Diagnostica Senese SpA ELISA Enzywell SARS-CoV-2 IgM (CE-IVD)
- Diesse Diagnostica Senese SpA ELISA Enzywell SARS-CoV-2 IgA (CE-IVD)
- DNA Software, Inc. Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A B (In development)
- DNA XPERTS XPERTS COVID19 - FAST RT-PCR KIT, Real time PCR kit for COVID19 detection (RUO)
- DNA-Technology R&D LLC SARS-CoV-2/SARS-CoV Multiplex REAL-TIME PCR Detection Kit (CE-IVD)
- DowGene Co., Ltd Dow QuickFinder-G 2019-nCoV Real-time PCR Kit (Korea MFDS EUA - CE-IVD)
- DowGene Co., Ltd Dow QuickFinder 2019-nCoV Real-time PCR Kit (Korea MFDS EUA - CE-IVD)
- DxGen Corp. Epithod® 616 COVID-19 IgG Test Kit (Korea export - CE-IVD)
- DxGen Corp. Epithod® SARS-CoV-2 qAg Test Kit (Korea export - French MOH - CE-IVD)
- DxGen Corp. Epithod® COVID-19 Ag Test Kit (Korea export - French MOH - CE-IVD)
- DxGen Corp. Epithod® 616 COVID-19 IgM/IgG Test Kit (Korea export - CE-IVD)
- Dynamiker Biotechnology (Tianjin) Co., Ltd Novel Coronavirus (2019-nCov) RT-PCR Kit (Philippines FDA - RUO)
- Dynamiker Biotechnology (Tianjin) Co., Ltd. Dynamiker SARS-CoV-2 Ag Rapid Test (CE-IVD)
- Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019 nCOV IgG/IgM Rapid Test (CE-IVD)
- Eagle Biosciences Inc. COVID-19 IgM ELISA Assay (RUO)
- Eagle Biosciences Inc. COVID-19 IgG ELISA Assay (RUO)
- Ebram Produtos Laboratoriais Ltd CORONAVÍRUS IgG/IgM (COVID-19) (Brazil ANVISA)
- Edinburgh Genetics Limited Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit (CE-IVD)
- Edinburgh Genetics Limited Edinburgh Genetics Complete Whole Blood Collection Kit (RUO)
- Edinburgh Genetics Limited Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined (CE-IVD)
- Edinburgh Genetics Limited Edinburgh Genetics COVID-19 Real-Time PCR Testing Kit (China NMPA EUA - CE-IVD)
- Edinburgh Genetics Limited Edinburgh Genetics Virus Swab Sampling Kit (RUO)
- Eiken Chemical Co., Ltd Loopamp SARS-CoV-2 Detection Kit (Japan PMDA - CE-IVD)
- Elabscience Novel Coronavirus (SARS-CoV-2) Nucleic Acid Assay Kit (RT-PCR) (RUO)
- Elabscience SARS-CoV-2 (2019-nCoV) IgG/IgM Lateral Flow Assay Kit (Whole Blood/ Serum/ Plasma) (RUO)
- Elisabeth Pharmacon spol. s.r.o. EliGene® COVID19 CONFIRM RT (CE-IVD)
- Elisabeth Pharmacon spol. s.r.o. EliGene® COVID19 BASIC A RT (CE-IVD)
- Elisabeth Pharmacon spol. s.r.o. EliGene® COVID19 BASIC A500 RT (CE-IVD)
- Eluceda Limited Eluceda Rapid RNA Covid-9 test (In development)
- EMG Detection Kit for the SARS-CoV-2 RNA Presence in Biological Material Using Real-Time (RUO)
- En Carta En Carta SARS-CoV-2 (In development)
- ender diagnostics ag enderLAB (CE-IVD)
- ender diagnostics ag enderMASS (CE-IVD)
- ender diagnostics ag enderMOBILE (In development)
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Epitope Diagnostics, Inc.
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Epitope Diagnostics, Inc.
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- Epitope Diagnostics, Inc. COVID-19 Nucleocapsid IgG Quantitative ELISA Kit (CE-IVD)
- Eudipia Co., Ltd EuDx™ COVID-19 Detection Kit (CE-IVD)
- Eurobio Scientific EurobioPlex SARS-CoV-2 Multiplex (CE-IVD)
- EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG) (US FDA EUA - Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)
- EUROIMMUN AG SARS-CoV-2 Antigen ELISA (CE-IVD)
- EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA) (Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)
- EUROIMMUN AG Anti-SARS-CoV-2-NCP ELISA (IgG) (CE-IVD)
- EUROIMMUN AG EURORealTime SARS-CoV-2 (US FDA EUA - Australia TGA - South Africa SAHPRA - CE-IVD)
- Eurospital S.p.A. SARS-COV-2 IgG (CE-IVD)
- FABPulous/DTwist BV DTwist
- Fast Track Diagnostics Luxembourg S.à r.l., a Siemens Healthineers Company FTD-114 SARS-CoV-2 (manual & lab-based NAT) (US FDA EUA - Singapore HSA - CE-IVD - WHO EUL)
- FemtoDx COVID-19 Rapid Home Nucleic Acid Test (In development)
- Finbiosoft Results Manager (automatic PCR interpretation software) (RUO)
- Fjord Diagnostics SDN BHD Fjord - Viral Transport Medium (VTM, alcohol formulation) (Malaysia MDA - CE-IVD)
- Fjord Diagnostics SDN BHD SEDIPREP COVID-19 (CE-IVD)
- Fluidigm Corporation Advanta Dx SARS-CoV-2 RT-PCR Assay (US FDA EUA - CE-IVD)
- FluroTest LLC CompleTest (In development)
- Fluxergy LLC Fluxergy Sample-to-Answer SARS-CoV-2 RT-PCR (In development)
- Fortress Diagnostics Ltd Coronavirus Antigen Rapid Test (CE-IVD)
- FUJIREBIO Inc. ESPLINE SARS-CoV-2 (Japan MHLW IVD - CE-IVD)
- GA Generic Assays GmbH GA CoV-2 IgG/IgM/IgG+ (CE-IVD)
- GaDia Diagnostics SA COVIDia - Antibody (RUO)
- GaDia Diagnostics SA COVIDia - Antigen (In development)
- GenBody, Inc. GenBody FIA COVID-19 IgM/IgG (manual) (RUO)
- GenBody, Inc. GenBody COVID-19 IgM/IgG 3.0 (RUO)
- GenBody, Inc. GenBody COVID-19 IgM/IgG (Australia TGA - Brazil ANVISA - CE-IVD)
- GenBody, Inc. GenBody COVID-19 Ag (CE-IVD)
- Gencurix Inc. GenePro COVID-19 Detection Test v2 (CE-IVD)
- Gencurix Inc. GenePro COVID-19 Detection Test (US FDA EUA - Philippines FDA - CE-IVD)
- genedrive plc Genedrive®96 SARS-CoV-2 Kit (CE-IVD)
- GeneFirst Ltd COVID-19 Plus Detection Kit (CE-IVD)
- GeneFirst Ltd The Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (CE-IVD)
- GeneFirst Ltd Respiratory Pathogen Panel (RUO)
- GeneFirst Ltd COVID-19 Plus Detection Kit SARS-CoV-2, Flu A/B & RSV (CE-IVD)
- Genelogic Research Limited Genelogic COVID-19 IgM/IgG Antibody Test Kit (Hong Kong MDACS - CE-IVD)
- GeneMatrix Inc. NeoPlex COVID-19 Detection Kit (US FDA EUA - India CDSCO - CE-IVD)
- GeneMe Sp. z.o.o. Advanced One Step FAST Covi19 KIT Two Genes Set (CE-IVD)
- GeneMe Sp. z.o.o. FRANKD (CE-IVD)
- geneOmbio Technologies Pvt. Ltd geneOmbio COVID-19 rt-LAMP test (RUO)
- GeneProof a.s. GeneProof SARS-CoV-2 Screening PCR Kit (CE-IVD)
- GeneProof a.s. GeneProof SARS-CoV-2 PCR Kit (CE-IVD)
- General Biologicals Corporation GB SARS-CoV-2 Ab ELISA (CE-IVD)
- General Biologicals Corporation GB Viral Transport Medium (VTM) Swab Kit (CE-IVD)
- General Biologicals Corporation GB SARS-CoV-2 Real Time RT-PCR (Taiwan FDA EUA - Australia TGA - India CDSCO - CE-IVD)
- GeneReach Biotechnology Corporation POCKIT™ Central SARS-CoV-2 (orf 1ab) Premix Reagent (Taiwan FDA EUA - CE-IVD)
- Generi Biotech s.r.o. gb SARS-CoV-2 N (confirmation test) (CE-IVD)
- Generi Biotech s.r.o. gb Sarbeco N (primary test) (CE-IVD)
- Generi Biotech s.r.o. gb Sarbeco E (primary test) (CE-IVD)
- Generi Biotech s.r.o. gb SARS-CoV-2 Multiplex (CE-IVD)
- Generi Biotech s.r.o. gb SARS-CoV-2 RdRP (confirmation test) (CE-IVD)
- Genesprint Group Ltd SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)
- Genesprint Group Ltd Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARSCoV-2 (CE-IVD)
- Genesystem, Co. Ltd SMARTCHEK SARS-CoV2 Detection Kit (Korea MFDS EUA - CE-IVD)
- Genetic Analysis AS GA-map® COVID-19 Fecal Test (CE-IVD)
- Genetic Signatures Limited EasyScreenTM Pan-Coronavirus/SARS-CoV-2 Detection Kit (Australia TGA - CE-IVD)
- Genitech NSAN Pharmaceutical Pvt. Ltd COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)
- GenMark Diagnostics ePlex® SARS-CoV-2 Test (US FDA EUA)
- Genobio Pharmaceutical Co., Ltd. COVID-19 IgG Antibody Detection Kit (CLIA) (CE-IVD)
- Genobio Pharmaceutical Co., Ltd. COVID-19 IgM Antibody Detection Kit (CLIA) (CE-IVD)
- Genobio Pharmaceutical Co., Ltd. COVID-19 IgG/IgM Lateral Flow Assay (CE-IVD)
- Genobio Pharmaceutical Co., Ltd. COVID-19 IgG Lateral Flow Assay (CE-IVD)
- Genobio Pharmaceutical Co., Ltd. COVID-19 IgM Lateral Flow Assay (CE-IVD)
- Genobio Pharmaceutical Co., Ltd. COVID-19 Antigen Lateral Flow Assay (CE-IVD)
- Genomax Technologies Pte Ltd Hangzhou Lysun 2019-nCoV IgG/IgM Rapid Test Device (Singapore HSA)
- GenomCan Inc. Fluorescent PCR Probe Detection Kit for SARS-CoV-2 (CE-IVD)
- Genomica Sau qCOVID-19 (CE-IVD)
- Genomica Sau CLART COVID-19 (CE-IVD)
- Genomictree, Inc. AccuraTect RT-qPCR SARS-CoV-2 (CE-IVD)
- Genomtec SA Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit (CE-IVD)
- GenoSensor, LLC GS™ COVID-19 RT-PCR KIT (US FDA EUA)
- GenoSUR LLC Sampling and transport device for SARS-CoV-2 and other respiratory viruses (Chile ISP)
- Genrui Biotech Inc. Fully-Auto Nucleic Acid Extraction Instrument (CE-IVD)
- Genrui Biotech Inc. Disposable Viral Sampling Tube (CE-IVD)
- Genrui Biotech Inc. SARS-CoV-2 and FluA+FluB Antigen Test Kit (CE-IVD)
- Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) (Brazil ANVISA - Singapore HSA - CE-IVD)
- Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) (CE-IVD)
- Genrui Biotech Inc. SARS-CoV-2/Flu A/Flu B Detection Kit (RT-PCR) (CE-IVD)
- Genrui Biotech Inc. Real-Time Fluorescence Quantitative PCR Instrument (CE-IVD)
- Genrui Biotech Inc. SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (CE-IVD)
- GenScript 2019-nCoV qRT-PCR Detection Assay (RUO)
- GenScript Biotech cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit (CE-IVD)
- GENSPEED Biotech Covid-19 Complete xPOC (In development)
- GENSPEED Biotech Covid-19 Ag xPOC (In development)
- GENSPEED Biotech Covid-19 IgG xPOC (CE-IVD)
- GenSure Biotech Inc. GenSure™ COVID-19 IgG/IgM Rapid Test (REF: P2002) (CE-IVD)
- GenSure Biotech Inc. GenSure™ COVID-19 IgM Rapid Test (REF: P2001) (CE-IVD)
- GenSure Biotech Inc. GenSure™ COVID-19 Antigen Rapid Kit (REF: P2004) (CE-IVD)
- GenSure Biotech Inc. COVID-19 Neutralizing Antibody Test (Latex) P2006 (CE-IVD)
- GenSure Biotech Inc. COVID-19 Neutralizing Antibody Test (Fluorescence) P2006 (CE-IVD)
- GenSure Biotech Inc. COVID-19/FluA/B Antigen Combo Rapid Test P2007 (CE-IVD)
- gerbion GmbH & Co., KG virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 (CE-IVD)
- Getein Biotech, Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody (Colloidal Gold) (India CDSCO - CE-IVD)
- Getein Biotech, Inc. Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit (CE-IVD)
- GFE SARS-CoV-2 PCR Reagent Kit (RUO)
- GNA Biosolutions GmbH SARS-CoV-2 Detection Kit on portable PCA Analyzer (In development)
- Goldsite Diagnostics Inc. SARS-CoV-2 IgG/IgM Kit (manual) (CE-IVD)
- Goldsite Diagnostics Inc. SARS-CoV-2 Antigen Kit (Colloidal Gold) (CE-IVD)
- Green Cross Medical Science Corp. GENEDIA W COVID-19 Ag (CE-IVD)
- Green Cross Medical Science Corp. GENEDIA W COVID-19 Colorimetric LAMP premix kit (CE-IVD)
- Green Cross Medical Science Corp. GENEDIA W COVID-19 Real-time RT-PCR kit (CE-IVD)
- Green Cross Medical Science Corp. GENEDIA W One COVID-19 IgM/IgG (CE-IVD)
- GRiSP Xpert qDetect COVID-19 (RUO)
- Guangdong Huayin Medicine Science Co,. Ltd Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised) (In development)
- Guangzhou Darui Biotechnology Co.,Ltd Novel Coronavirus 2019-nCoV IgM Antibody Detection Kit (Colloidal Gold Method) (RUO)
- Guangzhou Darui Biotechnology Co.,Ltd 2019 Novel Coronavirus (2019-nCoV) IgM Antibody Detection Kit (ELISA Method) (RUO)
- Guangzhou Darui Biotechnology Co.,Ltd Novel Coronavirus 2019-nCoV IgG Antibody Detection Kit (Colloidal Gold Method) (RUO)
- Guangzhou Darui Biotechnology Co.,Ltd 2019 Novel Coronavirus (2019-nCoV) IgG Antibody Detection Kit (ELISA Method) (RUO)
- Guangzhou Fenghua Bioengineering , Co. LTD Combined Detection Kit for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody (RUO)
- Guangzhou FulenGen Co., Ltd RT-qPCR based SARS-CoV-2 detection kit with SPRS (Spike-in Reference Standard) (In development)
- Guangzhou HEAS BioTech Co., Ltd 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) (RUO)
- Guangzhou Hybribio Medicine Technology Ltd Respiratory Virus (IFVa/b + COVID-19) Real-Time PCR Kit (In development)
- Guangzhou Sagene Biotech Co., Ltd Detection Kit for novel Coronavirus (SARS-CoV-2) ORF1ab gene and N gene (RUO)
- Guangzhou Supbio Biotechnologies, Inc. Supbio SARS-CoV-2 (ORF1ab/N) (Nucleic Acid Detection Kit/PCR-Fluorescent) (RUO)
- Guangzhou Tebsun Bio-Tech Development Co., Ltd SARS-CoV-2 Nucleic Acid Test (LAMP) (CE-IVD)
- Guangzhou Tebsun Bio-Tech Development Co., Ltd SARS-CoV-2 IgM/IgG Antibody Test（Colloidal Gold Immunochromatographic Assay） (CE-IVD)
- Guangzhou Wondfo Biotech Co., Ltd Wondfo SARS-CoV-2 Nucleic Acid Detection Kit (RUO)
- Guangzhou Wondfo Biotech Co., Ltd Wondfo SARS-CoV-2 Antibody Test (lateral flow method) (Singapore HSA - China NMPA EUA - Australia TGA - Brazil ANVISA - India CDSCO - CE-IVD)
- Hai Kang Life Corporation Ltd C/Tech SARS-COV-2 RT-PCR Technology (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd 2019-nCoV IgG/IgM Rapid Test Cassette (whole blood, serum, plasma) (Brazil ANVISA - Australia TGA - CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 Antigen Rapid Test (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 Antigen Test cassette (FIA) (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 Antigen Rapid Test ( Oral Fluid) (RUO)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 Antigen Rapid Test with Reader (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 and Influenza A+B Antigen Combo Rapid Test with Reader (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd SARS-COV-2 RT-qPCR Assay (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 and Influenza A+B Antigen Combo Rapid Test (CE-IVD)
- Hangzhou Bigfish Bio-tech Co., Ltd LAMP kit for qualitative detection of SARS-CoV-2 (In development)
- Hangzhou Bigfish Bio-tech Co., Ltd The golden standard of SARS-CoV-2 viral nucleic acid detection (In development)
- Hangzhou Biotest Biotech Co., Ltd RightSign COVID-19 IgG/IgM Rapid Test Cassette (US FDA EUA - Brazil ANVISA - Australia TGA - India CDSCO - CE-IVD)
- Hangzhou Clongene Biotech Co., Ltd 2019-nCoV IgG/IgM Rapid Test Cassette (Australia TGA - Brazil ANVISA - CE-IVD)
- Hangzhou Clongene Biotech Co., Ltd COVID-19 Antigen Rapid Test Cassette (Saliva) (CE-IVD)
- Hangzhou Clongene Biotech Co., Ltd COVID-19 Influenza A+B Antigen Combo Rapid Test Cassette (CE-IVD)
- Hangzhou Clongene Biotech Co., Ltd COVID-19 Antigen Rapid Test Cassette (CE-IVD)
- Hangzhou Clongene Biotech Co., Ltd SARS-CoV-2 Nucleic Acid RT-PCR Test Kit (CE-IVD)
- Hangzhou Dan Wei Biotechnology Co.Ltd 2019-nCoV Direct RT-qPCR Kit (In development)
- Hangzhou Deangel Biological Engineering Co., Ltd Novel Coronavirus S Glycoprotein Detection Kit (Brazil ANVISA - CE-IVD)
- Hangzhou Dian Biotechnology Co., Ltd Real-time RT-PCR Detection Kit For 2019-nCoV (CE-IVD)
- Hangzhou Fenhe Technology Co. Ltd reOpenTest COVID-19 Antigen Rapid Test (CE-IVD)
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd Extended ViralTrans, Extended EnteroTrans, Sampling & Transport System (CE-IVD)
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd COVID-19 IgG/IgM Rapid Test Device (CE-IVD)
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd Viral Transport Medium (US FDA EUA - CE-IVD)
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd COVID-19 Antigen Rapid Test Device (CE-IVD)
- Hangzhou Laihe Biotech Co., Ltd LYHER Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) (US FDA EUA - Australia TGA - Brazil ANVISA - CE-IVD)
- Hangzhou Life Real Biotechnology Co., Ltd COVID-19 nucleic acid (RNA) POCT detection kit (AIGS real-time fluorescent PCR method) (CE-IVD)
- Hangzhou Matridx Biotechnology Co., Ltd 2019-nCov Rapid Test Kit (RUO)
- Hangzhou Realy Tech Co., Ltd 2019-nCOV LgG/LgM Rapid Test Device (CE-IVD)
- Hangzhou Testsea Biotechnology Co., Ltd New Coronavirus COVID-19 Nucleic Acid Detection Kit (Fluorescent PCR Method) (RUO)
- Hangzhou Testsea Biotechnology Co., Ltd COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)
- Hayat Genetics Inc. Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit (CE-IVD)
- Hecin Scientific, Inc. COVID-19 IgM Antibody Rapid Test Kit (China NMPA EUA - Brazil ANVISA - CE-IVD)
- Hemcheck Sweden AB HELGE™: POC-test for rapid and objective detection of hemolysis in blood samples aimed for SARS-CoV-2 antibody testing for prevention of sample rejection in the laboratory (CE-IVD)
- HiberGene Diagnostics HG Covid-19 (CE-IVD)
- Hologic Inc. Panther Fusion SARS-CoV-2 assay (US FDA EUA - Health Canada - Australia TGA)
- Hologic Inc. Aptima SARS-CoV-2 Assay (US FDA EUA - Australia TGA - Singapore HSA - India CDSCO - Saudi FDA)
- Hoyotek Biomedical Co., Ltd Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal Gold) (CE-IVD)
- Hoyotek Biomedical Co., Ltd Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) (CE-IVD)
- Hoyotek Biomedical Co., Ltd Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) (CE-IVD)
- Hughes Healthcare UK SARS-CoV-2 Antigen Rapid Test (MHRA UK - CE-IVD)
- Humasis Humasis COVID-19/Flu Ag Combo Test (Korea MFDS EUA - CE-IVD)
- Humasis Humasis COVID-19 IgG/IgM Test (Korea MFDS EUA - Brazil ANVISA - CE-IVD)
- Humasis Humasis COVID-19 Ag Test (Korea MFDS EUA - CE-IVD)
- Hunan Lituo Biotechnology Co., Ltd COVID-19 IgG/IgM Detection Kit (Colloidal Gold) (India CDSCO - CE-IVD)
- Hunan Yonghe-Sun Biotechnology Co., Ltd SARS-COV-2 specific antibody test kit (Immunochromatography) (RUO)
- Huwel Lifesciences Pvt. Ltd. Quantiplus CORONA Virus (2019nCoV) detection kit (In development)
- Hyris Ltd bKIT Virus finder COVID-19 (Health Canada - CE-IVD)
- ICBFM LAMP kit for qualitative detection of SARS-CoV-2 (RUO)
- Icosagen AS Icosagen Covid-19 ELISA Kit (CE-IVD)
- ID.vet ID Screen®SARS-CoV-2-N IgG Indirect ELISA Kit (manual, automated) (CE-IVD)
- Ideal Tashkhis Atieh Co. SARS-CoV-2 IgG ELISA Kit (CE-IVD)
- Ideal Tashkhis Atieh Co. SARS-CoV-2 IgM ELISA Kit (CE-IVD)
- idil biotech RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit (CE-IVD)
- idil biotech RevoDx SARS-CoV-2 qPCR Kit (CE-IVD)
- Immunostep S.L. Anti-SARS-CoV-2 ELISA IgA (CE-IVD)
- Immunostep S.L. Anti-SARS-CoV-2 ELISA IgG (CE-IVD)
- IMMY clarus SARS-CoV-2 Total Antibody EIA (CE-IVD)
- Imunodiagnostika SARS-CoV-2 S IgG ELISA (CE-IVD)
- InBios International, Inc. InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit (US FDA EUA - RUO)
- InDevR Inc. COVID Serology Kit: Multiplexed Immunoassay (RUO)
- Ingenetix ViroReal® Kit SARS-CoV-2 & SARS (CE-IVD)
- Ingenuity Diagnostics Inc. Home Collection Kit (In development)
- Ingenuity Diagnostics Inc. Viral Transport Medium - BGX (VTM) (US FDA EUA)
- Ingenuity Diagnostics Inc. Saliva Collection kit (In development)
- Ingenuity Diagnostics Inc. RT-PCR kit (US FDA EUA)
- Ingenuity Diagnostics Inc. RT-PCR Direct with VTM (In development)
- Ingenuity Diagnostics Inc. Flu SC2 Multiplex Assay (In development)
- Innocreate Bioscience Co., Ltd Innocreate SARS-CoV-2 QD kit (Taiwan FDA EUA)
- Innovita (Tangshan) Biological Technology Co., Ltd Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (Multiple Fluorescence PCR) (RUO)
- Innovita Biological Technology Co. Ltd 2019-nCoV Antibody Test (Colloidal Gold) (China NMPA EUA - Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)
- Institut Virion Serion GmbH SERION ELISA agile SARS-CoV-2 IgA - ESR400A (CE-IVD)
- Institut Virion Serion GmbH SERION ELISA agile SARS-CoV-2 IgM - ESR400M (RUO)
- Institut Virion Serion GmbH SERION ELISA agile SARS-CoV-2 IgG - ESR400G (CE-IVD)
- Institute of Process Engineering, Chinese Academy of Sciences Coronavirus Disease 2019 (COVID-19) Nucleic Acid Testing Kit (CAMP-based) (In development)
- Instituto de Medicina Genómica Imegen SARS-CoV-2 (CE-IVD)
- Intavis Peptide Services GmbH & Co. KG Covid19-hullB CelluSpot™ Array (RUO)
- InTec Products, Inc. Rapid SARS-CoV-2 Antibody Test (CE-IVD)
- InTec Products, Inc. Rapid SARS-CoV-2 Antibody (IgM/IgG) (CE-IVD)
- Integrated Nano Technologies Palladium System (In development)
- Intrasense SA Myrian Covid-19 (China NMPA EUA - US FDA EUA - CE-IVD)
- iNtRON Biotechnology Inc. LiliF™ COVID-19 Real-time RT-PCR Kit (In development)
- IVDbio Inc. Machine-Free, Fast and Accurate Nucleic Acid Diagnoses System for COVID-19 (In development)
- iXensor PixoTest® COVID-19 Antigen Test (RUO)
- Jetta Labs LLP OZO India SARS-CoV2 (COVID-19) lgG/lgM Test (Colloidal Gold Method) (CE-IVD)
- Jetta Labs LLP OZO Diamond SARS-CoV2 (COVID-19) lgG/lgM Test (Latex Method) (CE-IVD)
- Jetta Labs LLP OZO Simcere Novel Coronavirus (2019-NCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (CE-IVD)
- Jetware SRL LOMT - Pool Testing Management Software (In development)
- Jiangsu Bioperfectus Technologies Co. Ltd COVID-19 Coronavirus Real Time PCR Kit (US FDA EUA - Australia TGA - Brazil ANVISA - Russia RZN - CE-IVD - WHO-EUL)
- Jiangsu Bioperfectus Technologies Co. Ltd Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit (Brazil ANVISA - CE-IVD)
- Jiangsu Bioperfectus Technologies Co. Ltd Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (CE-IVD)
- Jiangsu Microdiag Biomedicine Technology Co., Ltd Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA (RUO)
- Jiangsu Microdiag Biomedicine Technology Co., Ltd Novel coronavirus 2019-nCoV nucleic acid detection kit (rRT- PCR method) (RUO)
- Jiangsu Mole Bioscience Co., Ltd SARS-Cov-2 Rapid IgM-IgG Antibody Test Kit (CE-VID)
- Jiangsu Mole Bioscience Co., Ltd 2019-Novel Coronavirus (ORF1ab, E & N genes) nucleic acid test kit (CE-VID)
- Jiangsu Mole Bioscience Co., Ltd SARS-CoV-2 Antigen Test Cassette (CE-VID)
- Jiangsu Qitian Gene Biotechnology Co., Ltd Fluorescent RAA Detection for 2019-nCoV (RUO)
- Jiangsu Superbio Biomedical Technology (Nanjing) Co., Ltd SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (US FDA EUA - CE-IVD)
- Jiangxi YeLi Medical Apparatus Detection Kit for Novel Coronavirus 2019-nCoV RNA (RT-PCR Fluorescence Probing) (RUO)
- JinHuan Medical Instrument Co., Ltd (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (CE-IVD)
- JN Medsys ProTect Covid-19 RT-qPCR kit (Singapore HSA - CE-IVD)
- Joinstar Biomedical Technology Co., Ltd COVID-19 Antigen Rapid Test (Latex) (CE-IVD)
- Joinstar Biomedical Technology Co., Ltd SARS-CoV-2 / Influenza A&B Antigen Rapid Test (CE-IVD)
- Joinstar Biomedical Technology Co., Ltd COVID-19 Antigen Rapid Test (Colloidal Gold) (CE-IVD)
- Joinstar Biomedical Technology Co., Ltd SARS-CoV-2 /MERS-CoV/ Influenza A&B Antigen Rapid Test (CE-IVD)
- Joinstar Biomedical Technology Co., Ltd COVID-19 Antigen Rapid Test (Colloidal Gold) (immunology sample) (CE-IVD)
- Joinstar Biomedical Technology Co., Ltd SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold) (CE-IVD)
- JOYSBIO (Tianjin) Biotechnology Co., Ltd COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)
- JOYSBIO (Tianjin) Biotechnology Co., Ltd COVID-19 Neutralizing Antibody Test Kit (Lateral Flow Rapid Test) (CE-IVD)
- JOYSBIO (Tianjin) Biotechnology Co., Ltd COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (CE-IVD)
- Kephera Diagnostics KDx COVID-19 IgG/IgM Rapid Detection Test Kit (In development)
- Kephera Diagnostics KDx SARS-CoV-2 IgG/IgM ELISA (In development)
- Kephera Diagnostics KDx Rapid SARS-CoV-2 Antigen Test (In development)
- KH Medical Co. Ltd RADI COVID-19 Detection Kit and RADI COVID-19 Triple Detection Kit (CE-IVD)
- Koch Biotechnology (Beijing) Co., Ltd SARS-CoV-2 Antigen Lateral Flow Assay (MHRA UK)
- KogeneBiotech Co. Ltd PowerChekTM 2019-nCoV Real-time PCR Kit (Korea MFDS EUA - US FDA EUA - CE-IVD)
- Kreative Technolabs Viral RNA Extraction Kit (RUO)
- KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual) (RUO)
- KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test (RUO)
- KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test (CE-IVD)
- KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual) (RUO)
- KRISHGEN BioSystems Human SARS-CoV-2 (Covid-19) ELISA (RUO)
- KRISHGEN BioSystems SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines) (CE-IVD)
- KRISHGEN BioSystems SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) ELISA (CE-IVD)
- KRISHGEN BioSytems Human SARS-CoV-2 (Covid-19) Qualitative ELISA (RUO)
- Krosgen Biotech KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit (CE-IVD)
- L&H Biotech Limited COVID-19 Antigen Rapid Test (In development)
- L7 Informatics Enterprise Science Platform (CLIA)
- LabGenomics Co., Ltd LabGun™ COVID 19 Assay PCR Kit (US FDA EUA - Australia TGA - South Africa SAHPRA - CE-IVD)
- Labnovation Technologies Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit (CE-IVD)
- Labnovation Technologies Inc. SARS-CoV-2 Antigen Rapid Test Kit (CE-IVD)
- Labsystems Diagnostics Oy COVID-19 Real Time Multiplex RT PCR Kit (Invima Colombia - CE-IVD)
- Labsystems Diagnostics Oy Biocard COVID-19 IgM/IgG Easy (CE-IVD)
- Labtest Diagnostica SA Anti COVID-19 IgG/IgM Rapid Test (Brazil ANVISA)
- Landcent Europe B.V. Real time RT-PCR Kit for the detection of SARS-CoV-2 (In development)
- Leadgene Biomedical, Inc. Leadgene® SARS/SARS-CoV-2 Antigen Rapid Test Kit (In development)
- Leadgene Biomedical, Inc. Leadgene® SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit (In development)
- LetsGetChecked LetsGetChecked Coronavirus (COVID-19) Test (US FDA EUA)
- LG Chem Life Sciences Company AdvanSure COVID-19 real-time RT-PCR (CE-IVD)
- LGC Biosearch technology Molecular assays, RNA extraction kit, rt-PCR reagents (China NMPA EUA - US FDA EUA)
- Lifeassay Diagnostics Pty Ltd LifeSADX CoV-2 IgT (Total antibody) (South Africa SAHPRA - MHRA UK)
- Lifeassay Diagnostics Pty Ltd Test-it CoV-2 IgM/IgG Test Kit (South Africa SAHPRA)
- LifeSensors, Inc. COVID-19 IgG ELISA Detection Kit (RUO)
- Liming Bio-Products Co., Ltd COVID-19 IgG/IgM Combo Rapid Test Device (Brazil ANVISA - CE-IVD)
- Liming Bio-Products Co., Ltd SrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (CE-IVD)
- Liming Bio-Products Co., Ltd COVID-19 Antigen Rapid Test Device (CE-IVD)
- LOMINA AG SARS-CoV-2 N-Protein Antigen Rapid Test (CE-IVD)
- LOMINA AG Fast COVID19 IgM/IgG Antibody Detection Kit (Colloidal Gold) (CE-IVD)
- Lumex Instruments Microchip RT-PCR COVID-19 detection system (RUO)
- Luminex Corp. ARIES SARS-CoV-2 Assay (US FDA EUA - Health Canada - Singapore HSA)
- Luminex Corp. NxTAG CoV Extended Panel (US FDA EUA - Health Canada)
- Luminostics, Inc. CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) (In development)
- LumiQuick Diagnostics Inc. Quicknostics® COVID-19 RT-PCR (Brazil ANVISA - CE-IVD)
- LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgG/IgM Combo Test Card (Brazil ANVISA - CE-IVD)
- LumiQuick Diagnostics Inc. QuickProfile™ COVID-19 ANTIGEN Test (Brazil ANVISA - Philippines FDA - CE-IVD)
- LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgM EIA Test (CE-IVD)
- LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgG EIA Test (CE-IVD)
- LumiraDx UK Ltd LumiraDx SARS-CoV-2 RNA STAR (US FDA EUA)
- LumiraDx UK Ltd LumiraDx SARS-CoV-2 Ag Test (US FDA EUA - CE-IVD)
- M monitor Inc. Isopollo COVID-19 detection Kit (real-time) (CE-IVD)
- Mabsky Bio-Tech Co., Ltd COVID-19 virus (2019-nCoV) Dual-Detection Kit (CE-IVD)
- Mabsky Bio-Tech Co., Ltd COVID-19 virus (2019-nCOV) Triple-Detection Kit (Real-Time PCR Method) (CE-IVD)
- Mabsky Bio-Tech Co., Ltd Influenza A virus, Influenza B virus & COVID-19 virus (2019-nCoV) Triple-Detection Kit (CE-IVD)
- Maccura Biotechnology Co., Ltd SARS-CoV-2 Nucleic Detection Kit (Fluorescent PCR) (China NMPA EUA - US FDA EUA - CE-IVD)
- Mammoth Biosciences SARS-CoV-2 DETECTR (US FDA EUA)
- Medical & Biological Laboratories Co., Ltd MEBRIGHT™ SARS-CoV-2 Kit (Japan MHLW IVD - CE-IVD)
- Medical Innovation Ventures Sdn Bhd. GenoAmp® Real-Time RT-PCR SARS-CoV-2 (CE-IVD)
- Medical System Coronavirus PCR test (China NMPA EUA - CE-IVD)
- MedicalSystem Biotechnology Co., Ltd COVID-19 IgM/IgG Rapid Test Cassette (CE-IVD)
- Mediclone Biotech Pvt Ltd @sight COVID-19 IgG/IgM Rapid Test Kit (In development)
- Medigen Biotechnology Corp. ExProbe SARS-CoV-2 Testing Kit (US FDA EUA - Taiwan FDA EUA - CE-IVD)
- Medigen Biotechnology Corp. TBG SARS-CoV-2 IgG/IgM Rapid Test Kit (US FDA EUA - India CDSCO - CE-IVD - Taiwan FDA EUA - Mexico COFEPRIS)
-
Medigen Vaccine Biologics Corp.
MVC SARS-CoV-2 Real-Time PCR Diagnostic Kit (CE-IVD)
-
Medigen Vaccine Biologics Corp.
MVC SARS-CoV-2 Convective PCR Diagnostic Device/Kit (RUO)
- Medisys International SA Gmate Covid-19 (CE-IVD)
- Medsource Ozone Biomedicals COVID 19 IgG IgM Rapid Test (India CDSCO)
- MedStar Medical Co., Ltd One-step Direct Realtime PCR Test Kit of 2019-nCoV Coronavirus (In development)
- Medusa 19 Ltd Rapid Saliva Protein Test (CE-IVD)
- Medusa 19 Ltd Rapid Saliva Protein Test & Saturn Pass Mobile App (CE-IVD)
- Megna Health Megna Health Rapid COVID-19 Antibody (IgM/IgG) Combo Test Kit (US FDA EUA)
- Meril Diagnostics Pvt Ltd Meril COVID-19 One-step RT-PCR Kit (India CDSCO)
- Merlin Biomedical (Xiamen) Co., Ltd Novel Coronavirus (COVID-19) RT-PCR Kit (CE-IVD)
- Merlin Biomedical (Xiamen) Co., Ltd 2019-nCoV IgG/IgM Rapid Test Cassette (CE-IVD)
- Merlin Biomedical (Xiamen) Co., Ltd SARS-CoV-2 Antigen Rapid Test Cassette (CE-IVD)
- Metas Biomedical Inc. ImmTek COVID-19 Antigen Rapid Test (CE-IVD)
- Mexacare Diagnostics GmbH Mexacare COVID-19 & Influenza A+B Ag Combo-Schnelltest (CE-IVD)
- Mexacare Diagnostics GmbH Mexacare COVID-19 Antigen Schnellltest (CE-IVD)
- Mexacare Diagnostics GmbH Mexacare COVID-19 IgG/IgM-Antikörper-Test (CE-IVD)
- MGI Tech Co., Ltd Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation (In development)
- MiCo Biomed Co. Ltd VERI-QTM PCR 316 COVID-19 detection system (Brazil ANVISA - Philippines FDA - RUO)
- MicroDigital Co., Ltd MDGen AB96-COVID-19 IgG (CE-IVD)
- Mikrogen GmbH recomLine SARS-CoV-2 IgG (CE-IVD)
- Mikrogen GmbH recomWell SARS-CoV-2 IgA (CE-IVD)
- Mikrogen GmbH recomWell SARS-CoV-2 IgG (CE-IVD)
- Mikrogen GmbH ampliCube Coronavirus Panel (CE-IVD)
- Mikrogen GmbH ampliCube Coronavirus SARS-CoV-2 (CE-IVD)
- Mobidiag Novodiag COVID-19 (CE-IVD)
- Mobidiag Novodiag® COVID-19 + InfA/B (lab-based & near-POC) (In development)
- Mobidiag Amplidiag COVID-19 (CE-IVD)
- Module Innovations Private Ltd nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual) (In development)
- Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay (CE-IVD)
- Molbio Diagnostics Pvt Ltd Truenat SARS CoV-2 (lab-based or near-POC) (India CDSCO)
- MolDiag by MAScIR MAScIR-SARS-CoV-2 PCR Kit (Morocco DMP-IVD - CE-IVD)
- Mologic Ltd SARS-CoV-2 Triple RDT (IgA/IgG/IgM) (RUO)
- Mologic Ltd SARS-CoV-2 ELISA Serology (RUO)
- Mologic Ltd Mologic COVID-19 Rapid Test (In development)
- MP Biomedicals MP Rapid 2019-nCoV IgG/IgM (CE-IVD)
- MP Biomedicals ASSURE SARS-CoV-2 IgG/IgM Rapid Test (Singapore HSA - CE-IVD)
- Multi-G B.V. COVID-19 IgG/IgM Ab Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)
- Mylab Discovery Solutions Pvt Ltd PathoDetect CoVID-19 Detection Kit (India CDSCO)
- myPOLS Biotec GmbH Direct SARS-CoV-2 PCR detection kit w/o extraction (In development)
- nal von minden GmbH NADAL® COVID-19 IgG/IgM Test (243003N-25, 243002N-20, 243001N-10) (CE-IVD)
- nal von minden GmbH NADAL® COVID-19 Ag (CE-IVD)
- Nanjing BioPoint Diagnostics BioPoint SARS-CoV-2 dIgA/total antibody rapid test (In development)
- Nanjing Vazyme Medical Technology Co., Ltd 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit (China NMPA EUA - CE-IVD)
- Nanjing Vazyme Medical Technology Co., Ltd 2019-Novel Coronavirus (2019-nCoV) IgG/IgM Detection Kit (China NMPA EUA - Brazil ANVISA - CE-IVD)
- Nanjing Weiyun Biotechnology Co., Ltd SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (CE-IVD)
- Nanjing Weiyun Biotechnology Co., Ltd SARS-CoV-2 Antigen Rapid Test Kit (Latex immunochromatography) (CE-IVD)
- Nanjing Weiyun Biotechnology Co., Ltd SARS-CoV-2 (COVID-19) Nucleic Acid Detection Kit (Fluorescent RT-PCR) (CE-IVD)
- Nano-Ditech Corporation Nano-Check COVID-19 Antigen Test (CE-IVD)
- Nano-Ditech Corporation Nano-Check COVID-19 IgG/IgM Antibody Test (CE-IVD)
- Nano-Ditech Corporation Fluoro-Check COVID-19 Antigen Test (CE-IVD)
- Nano-Ditech Corporation Nano-Check COVID-19 IgG Antibody Test (CE-IVD)
- NanoBio Lab, A*STAR Research Entities Isothermal Exponential Amplification for COVID-19 Detection (RUO)
- NanoEntek Inc. FREND™ COVID-19 Ag (Korea export - CE-IVD)
- NanoEntek Inc. En-swer™ COVID-19 RT-PCR Kit (Korea export - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 total Ab (US FDA EUA - Korea export - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 SP (Korea MFDS EUA - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 IgG/IgM Duo (Korea MFDS EUA - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 Ag + Flu A&B (Korea export - CE-IVD)
- Nantong Egens Biotechnology Co., Ltd COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (Australia TGA - Brazil ANVISA - CE-IVD)
- National Institute for Control of Vaccines and Biologicals Accupid nCoV 2019 Detection Kit (RUO)
- NDFOS Co., Ltd ND COVID-19 Detection Kit (Korea MFDS EUA - CE-IVD)
- NDFOS Co., Ltd ND COVID-19 IgG/IgM Rapid Test (Korea MFDS EUA - CE-IVD)
- Neomedica d.o.o. NAISSA SARS COV-2 IgA/IgM/IgG (CE-IVD)
- Neurix SA Spike neutralization assay (In development)
- Next Pharma Inc. DiaCarta's QuantiVirus™SARS-CoV-2 Test (US FDA EUA - CE-IVD)
- NG Biotech NG-Test IgG-IgM COVID-19 (CE-IVD)
- Ningbo Health Gene Technologies Co. Ltd. SARS-CoV-2 Virus Detection Diagnostic Kit (RT- qPCR Method) (RUO - WHO EUL)
- NIPD Genetics SARS-CoV-2 RT-qPCR Kit (CE-IVD)
- Nirmidas Biotech, Inc. pGOLD COVID-19 IgG/IgM/IgA Microarray Test (RUO)
- Nirmidas Biotech, Inc. Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit (RUO)
- Norgen Biotek Corp COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx (CE-IVD)
- Norgen Biotek Corp COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx (CE-IVD)
- Norgen Biotek Corp Total RNA Purification Kit Dx (Dx17200) (CE-IVD)
- Norgen Biotek Corp Swab Collection and Total Nucleic Acid Preservation System (68800) (RUO)
- Norgen Biotek Corp Saliva / Swab RNA Purification Kit Dx (CE-IVD)
- Norgen Biotek Corp Saliva RNA Collection and Preservation Devices RU53800 (RUO)
- Norgen Biotek Corp 2019-nCoV TaqMan RT-PCR Kit (RUO)
- NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgG (CE-IVD)
- NovaTec Immundiagnostica GmbH GSD NovaType SARS-CoV-2 ID (RUO)
- NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgM (CE-IVD)
- NovaTec Immundiagnostica GmbH GSD NovaType SARS-CoV-2 Detect & ID (RUO)
- NovaTec Immundiagnostica GmbH GSD NovaPrime® SARS-CoV-2 (COVID-19) (CE-IVD)
- NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgA (CE-IVD)
- NTBio Diagnostics Inc. COVID-19 IgG/IgM Antibody Test Cassette (Australia TGA - CE-IVD)
- NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RdRp and N Genes, CE-IVD (CE-IVD)
- NZYTech SARS-CoV-2 One-Step RT-PCR Kit, CE-IVD (MD03201) (CE-IVD)
- NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RUO (MD03191) (RUO)
- NZYTech NZY Viral RNA Isolation kit (RUO)
- Operon SA Simple/Stick Ag SARS-CoV-2 (COVID-19) (CE-IVD)
- Operon SA Real SARS-CoV-2 (CE-IVD)
- Operon SA Real SARS-CoV-1/2 (CE-IVD)
- OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT-PCR Test (US FDA EUA - CE-IVD)
- Optolane Technologies Inc. Dr. PCR COVID-19 Viral Load 20K (lab-based) (RUO)
- Optolane Technologies Inc. Kaira 2019-nCoV Detection kit (US FDA EUA - Philippines FDA - CE-IVD)
- Orpheus Medica Inc. CoviSafe™ (In development)
- Ortho Clinical Diagnostics VITROS® Immunodiagnostic Products SARS-CoV-2 Antigen (CE-IVD)
- Ortho Clinical Diagnostics VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total (US FDA EUA - Singapore HSA - Australia TGA)
- Ortho Clinical Diagnostics VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG (US FDA EUA)
- OsangHealthcare GeneFinder COVID-19 Plus RealAmp Kit (Health Canada - Brazil ANVISA - Singapore HSA - CE-IVD)
- Oxsed Limited Oxsed RaViD Direct SARS-COV-2 Test (CE-IVD)
- Pantest SA Pantest Coronavirus Ag (INFARMED - CE-IVD)
- Pantest SA Pantest Coronavirus IgM/IgG (CE-IVD)
- Paragon Genomics Inc. CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel (RUO)
- PathoFinder RealAccurate Quadruplex Corona-plus PCR Kit (CE-IVD)
- PathoFinder RealAccurate Quadruplex SARS-CoV2 PCR Kit (CE-IVD)
- PaxGen Bio Co. Ltd PaxView COVID-19 real time RT-PCR (CE-IVD)
- PCL Inc. PCL COVID19 Ag Gold (CE-IVD)
- PCL Inc. PCL COVID19 Ag Rapid FIA (CE-IVD)
- PCL Inc. PCL COVID19 IgG/IgM Rapid Gold (Korea MFDS EUA - Australia TGA - CE-IVD)
- PCL Inc. PCLMD™ nCoV one step RT-PCR Kit (Korea MFDS EUA - Health Canada - Singapore HSA - South Africa SAHPRA - Brazil ANVISA - CE-IVD)
- PEPperPRINT GmbH PEPperCHIP® SARS-CoV-2 Proteome Microarray (manual) (CE-IVD)
- PerGrande BioTech Development Co., Ltd SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) (CE-IVD)
- PerkinElmer Inc. PerkinElmer® SARS-CoV-2 Realtime RT-PCR Assay (US FDA EUA - Health Canada - Singapore HSA - South Africa SAHPRA - Philippines FDA - Australia TGA - CE-IVD - WHO EUL)
- PharmAct AG SARS COVID-19 Rapid Test (CE-IVD)
- Pharmaline Saglik Hizmetleri Ticaret A.S. COVIDİGEN Multiplex COVID-19 qRT-PCR KIT (CE-IVD)
- Pharmaline Saglik Hizmetleri Ticaret A.S. LAMPIGEN COVID-19 RT LAMP Kit (CE-IVD)
- Pinpoint Science Inc. Pinpoint Covid-19 Screening Assay (In development)
- Pishtaz Teb Diagnostics SARS-CoV-2 IgM ELISA Kit (CE-IVD)
- Pishtaz Teb Diagnostics COVID-19 One-Step COVID-19 RT-PCR Kit (CE-IVD)
- Pishtaz Teb Diagnostics SARS-CoV-2 IgG ELISA Kit (CE-IVD)
- PlexBio Co., Ltd PlexBio CoVid19/SARS/Influenza A, B Detection kit (In development)
- Prantae Solutions Pte Ltd EyeRa-Covid (In development)
- PreciGenome LLC FastPlex Triplex SARS-CoV-2 detection kit (US FDA EUA - CE-IVD)
- Precision Biosensor, Inc. PBCheck COVID-19 IgG/IgM (CE-IVD)
- Precision Biosensor, Inc. Exdia COVID-19 Ag (Korea export - CE-IVD)
- Precision Biosensor, Inc. Exdia COVID-19 IgG/IgM (CE-IVD)
- Predigen Inc. HR-PreV (In development)
- Premier Medical Corporation Pvt. Ltd SureStatus COVID-19 (SARS-CoV-2) Card Test (In development)
- Premier Medical Corporation Pvt. Ltd SureStatus COVID-19 (SARS-CoV-2) EIA Test (In development)
- PRIMA Lab S.A. PRIMA COVID-19 IgG/IgM Rapid Test (CE-IVD)
- PRIMA Lab SA COVID-19 Antigen Rapid Test (CE-IVD)
- PRIME4DIA Co., Ltd P4DETECT COVID-19 SAg (RUO)
- PRIME4DIA Co., Ltd P4DETECT COVID-19 Ag (RUO)
- PRIME4DIA Co., Ltd P4DETECT COVID-19 IgM/IgG (CE-IVD)
- Primerdesign Ltd genesig Real-Time PCR COVID-19 (US FDA EUA - Singapore HSA - CE-IVD)
- Progenie Molecular S.L.U. RealCycler CORO (CE-IVD)
- ProGnosis Biotech Bio-Shield 2019-nCoV IgM (CE-IVD)
- ProGnosis Biotech Bio-Shield 2019-nCoV IgG (CE-IVD)
- ProGnosis Biotech Rapid test 2019-nCoV Total Ig Immunoglobulins (IgA, IgG, IgM) (CE-IVD)
- ProGnosis Biotech Bio-Shield 2019-nCoV Total Immunoglobulins (IgA, IgG, IgM) (CE-IVD)
- ProGnosis Biotech Rapid test 2019-nCoV IgM/IgG (CE-IVD)
- ProGnosis Biotech Rapid Test Ag 2019-nCoV (CE-IVD)
- Prometheus Bio Inc. 2019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma) (CE-IVD)
- Promis Diagnostics SensDtect RT-qPCR SARS CoV-2 (RUO)
- PROMOITALIA GROUP SPA SARS-CoV-2 Antibody Test (CE-IVD)
- PROMOITALIA GROUP SPA DROP-TECH (CE-IVD)
- ProteomeTech Inc. GENEdania COVID-19 qRT-PCR (CE-IVD)
- ProteomeTech Inc. KOVIcheck COVID-19 IgG/IgM (CE-IVD)
- QIAGEN GmbH QIAstat-Dx Respiratory Panel 2019-nCoV (US FDA EUA - Australia TGA - Health Canada - Singapore HSA - Philippines FDA - CE-IVD)
- Qingdao Funuo Biomedical Co., Ltd COVID-19 Multiplex Fluorescent PCR Kit (CE-IVD)
- Qingdao Hightop Biotech Co., Ltd Hightop COVID-19 IgM/IgG Ab Rapid Test Kit (South Africa SAHPRA - Australia TGA - Brazil ANVISA - CE-IVD)
- Qingdao Jianma Gene Technology Co., Ltd. COVID-19 Nucleic Acid Detection Kit (Rapid PCR Fluorescence Method) (RUO)
- Quadratech Diagnostics Ltd COVID-19-CHECK-1 (CE-IVD)
- Quansys Biosciences SARS-CoV-2 Human IgG (4-Plex) (In development)
- QuantuMDx QPOC™ Point of Care NAT for SARS-CoV-2 (In development)
- QuantuMDx QuantuMDx NAT for SARS-CoV-2 (CE-IVD)
- Quick Energy Technologies Limited MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay) (CE-IVD)
- Quidel Sofia 2 Flu + SARS Antigen FIA (US FDA EUA)
- Quidel Sofia 2 SARS Antigen FIA (US FDA EUA)
- Quidel Lyra SARS-CoV-2 Assay (US FDA EUA - Health Canada - CE-IVD)
- QuikPath Pte Ltd QuikPath Covid-19 POC molecular test (Singapore HSA)
- Quotient Suisse SA MosaiQ™ COVID-19 Antibody Microarray (US FDA EUA - CE-IVD)
- R-Biopharm AG RIDA® GENE SARS-CoV-2 RUO (PG6815RUO) (CE-IVD)
- RainSure Scientific Co., Ltd RainSure COVID-19 dPCR Detection Kit (lab-based) (RUO)
- Randox Laboratories Ltd Extended Coronavirus Array (lab-based or near-POC) (RUO)
- Rapid Bio LLC Rapid test for IgM/IgG antibodies against SARS-COV-2 (RUO)
- RapiGEN Inc. BIOCREDIT COVID-19 Ag (Brazil ANVISA - Philippines FDA - CE-IVD)
- RapiGEN Inc. BIOCREDIT COVID-19 IgG+IgM Duo (CE-IVD)
- RapiGEN Inc. BIOCREDIT COVID-19 IgG (RUO)
- RayBiotech Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) (CE-IVD)
- Redcliffe Bioscience Redcliffe Bioscience LightPower iVA-SARS-COV-2 One Step RT-rPCR KIT (Vietnam MoH - CE-IVD)
- Redcliffe Bioscience SARS – CoV2 lgG ELISA SARS & CoV2 lgM ELISA (µ-Capture) (CE-IVD)
- Resilient Supplier Resilient Rápido Direct Read SARS-CoV-2 Antigen Paper-Strip Test Kit (CE-IVD)
- Resilient Supplier Resilient & Rápido Direct Read SARS-CoV-2 Antigen Test Cassette KIT (CE-IVD)
- Resilient Supplier Resilient & Rápido Direct Read SARS-CoV-2 Antigen Influenza A/B Test (CE-IVD)
- Reszon Diagnostics International Sdn Bhd Reszon COVID-19 Rapid Antigen Test (CE-IVD)
- Reszon Diagnostics International Sdn Bhd Reszon COVID-19 Rapid IgG/IgM Test (Malaysia MDA - CE-IVD)
- RetroVirox Inc. SARS-CoV-2 Pseudovirus assay for Neutralizing Antibodies (RUO)
- Rheonix, Inc. Rheonix COVID-19 MDx Assay (US FDA EUA - Australia TGA - Singapore HSA)
- Ring Biotechnology Co., Ltd COVID-19 IgM/IgG Rapid Test Kit (CE-IVD)
- Roche Elecsys Anti‐SARS‐CoV‐2 (US FDA EUA - Australia TGA - Health Canada - Brazil ANVISA - Singapore HSA - South Africa SAHPRA - CE-IVD)
- Roche Molecular Diagnostics cobas® SARS-CoV-2 (for use on the cobas® 6800/8800 Systems) (US FDA EUA - Health Canada - Brazil ANVISA - Australia TGA - Singapore HSA - South Africa SAHPRA - WHO EUL)
- Romed-Holland – Van Oostveen Medical B.V. Romed COVID-19 lgG/lgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)
- Romed-Holland – Van Oostveen Medical B.V. Romed Coronavirus Ag Rapid Test Cassette (Swab) (CE-IVD)
- RPC Diagnostic Systems Anti-SARS-CoV-2 Enzyme immunoassay for the detection of antibodies to SARS-CoV-2 (COVID-19) (CE-IVD)
- RPC Diagnostic Systems DS-ЕIA-Anti-SARS-CoV-2-G Enzyme immunoassay for the detection of IgG - antibodies to SARS-CoV-2 (COVID-19) (CE-IVD)
- Sacace Biotechnologies SARS-CoV-2 Real-TM (CE-IVD)
- Saladax Biomedical Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (CE-IVD)
- Sansure Biotech, Inc. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (US FDA EUA - China NMPA EUA - Singapore HSA - Australia TGA - South Africa SAHPRA - CE-IVD)
- Saturn Pass Saturn Pass Mobile App (MHRA UK - CE-IVD)
- ScheBo Biotech AG ScheBo® SARS-CoV-2 Quick™ Antigen (CE-IVD)
- ScheBo Biotech AG ScheBo® SARS-CoV-2 Quick™ IgM/IgG (US FDA EUA - India CDSCO - Brazil ANVISA - CE-IVD)
- Schweitzer Biotech Company Ltd SBC RNP qPCR Kit (RUO)
- Schweitzer Biotech Company Ltd SBC SARS-CoV-2 Convective PCR Diagnostic Device/Kit (RUO)
- Schweitzer Biotech Company Ltd SBC SARS-CoV-2 qPCR Kit (CE-IVD)
- Scope Fluidics SA PCR|COV (In development)
- SD BIOSENSOR Inc. STANDARD M nCoV Real-Time Detection Kit (US FDA EUA - Korea MFDS EUA - Brazil ANVISA - Philippines FDA - CE-IVD)
- SD BIOSENSOR, Inc. STANDARD F COVID-19 Ag FIA (Brazil ANVISA - CE-IVD)
- SD BIOSENSOR, Inc. STANDARD E COVID-19 Total Antibody Test (RUO)
-
SD BIOSENSOR, Inc.
STANDARD Q COVID-19 Ag Test (South Africa SAHPRA - Brazil ANVISA - CE-IVD - WHO EUL)
(validated ICMR)
- SD BIOSENSOR, Inc. STANDARD Q COVID-19 IgM/IgG Duo Test (Brazil ANVISA - CE-IVD)
- SEASUN BIOMATERIALS AQ-TOP™ COVID-19 Rapid Detection Kit (US FDA EUA - CE-IVD)
- SEASUN BIOMATERIALS U-TOP™ COVID-19 Detection Kit (US FDA EUA - Korea MFDS EUA - Singapore HSA - China NMPA EUA - CE-IVD)
- Seegene, Inc. Allplex 2019-nCoV assay (US FDA EUA - Health Canada - Australia TGA - Korea MFDS EUA - Singapore HSA - South Africa SAHPRA - Brazil ANVISA - CE-IVD)
- Selfdiagnostics Deutschland GmbH Multitest (In development)
- Sengenics Corporation Pte Ltd ImmuSAFE™ COVID Protein Microarray (RUO)
- Sengenics Corporation Pte Ltd ImmuSAFE™ Respiratory Virus Protein Microarray (RUO)
- Sengenics Corporation Pte Ltd ImmuSAFE™ COVID+ Protein Microarray (RUO)
- SensingSelf, Pte, Ltd S4 - Multiplex Rapid Antigen Test - COVID-19/MERS/Influenza A/Influenza B (CE-IVD)
- SensingSelf, Pte, Ltd S1 COVID-19 Rapid Antigen Test (CE-IVD)
- SensingSelf, Pte, Ltd, Singapore COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401) (India CDSCO - CE-IVD)
- Sensitest The Netherlands BV Sensitest Joysbio Antigen Rapid Test for Covid-19 (China NMPA EUA - CE-IVD)
- Sente Biolab Senteligo Covid-19 qRT PCR Detection Kit (CE-IVD)
- Sentinel CH STAT-NAT® Covid-19 HK and STAT-NAT® Covid-19 B (Philippines FDA - CE-IVD)
- Seramun Diagnostica GmbH Serazym Anti-SARS-CoV-2 RBD IgG ELISA (RUO)
- servoprax GmbH Cleartest Corona, Covid-19 (CE-IVD)
- SGA Medikal SARS-CoV-2 Rapid Ag Test Kit (Colloidal Gold) (CE-IVD)
- SGA Medikal SARS-CoV-2 Rapid Ag Test Kit (IFA) (CE-IVD)
- Shaanxi Lifegen Co., Ltd Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method) (CE-IVD)
- Shandong Shtars Biological Industry Co., Ltd Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit User Manual (RUO)
- Shandong ThinkLab Biotechnology Co., Ltd 2019-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Diagnostic Kit (Colloidal gold) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd COVID-19 and Influenza A+B Antigen Combo Rapid Test (Colloidal Gold) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Colloidal Gold) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd COVID-19/Influenza A+B/RSV/Antigen Combo Rapid Test (Colloidal Gold) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd Covid-19 Antigen Rapid Test (Colloidal gold) (CE-IVD)
- Shanghai Fosun Long March Medical Science Co., Ltd Fosun Novel Coronavirus (2019-nCoV) IgG/IgM rapid test kit (Immunofluorescence) (Brazil ANVISA - CE-IVD)
- Shanghai Fosun Long March Medical Science Co., Ltd Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit (US FDA EUA - Australia TGA - Brazil ANVISA - China NMPA EUA - Singapore HSA - CE-IVD - WHO EUL)
- Shanghai GeneoDx Biotechnology Co., Ltd Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method) (China NMPA EUA - WHO EUL)
- Shanghai Igenetec Diagnostics Co., Ltd Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip) (RUO)
- Shanghai Kehua Bio-engineering Co., Ltd Diagnostic kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) (CE-IVD)
- Shanghai Kehua Bio-engineering Co., Ltd SARS-CoV-2 Nucleic Acid Test (RUO)
- Shanghai LiangRun Biomedicine Technology Co. Ltd Diagnostic Kit for IgM/IgG Antibody of SARS-CoV-2 (Collodial Gold /Lateral Flow) (Brazil ANVISA - Singapore HSA - CE-IVD)
- Shanghai Outdo Biotech Co., Ltd Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold) (China NMPA EUA - Brazil ANVISA - CE-IVD)
- Shanghai Rendu Biotechnology Co., Ltd AmpSure 2019-nCov RNA Assay (RUO)
- Shanghai ZJ Bio-Tech Co., Ltd/Liferiver Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit (China NMPA EUA - Australia TGA - Singapore HSA - South Africa SAHPRA - CE-IVD - WHO EUL)
- ShanXi Medical University SARS-COV-2 IgM/IgG antibody test (Colloidal Gold) (RUO)
- Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Total Ab GICA Rapid Test (CE-IVD)
- Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) (CE-IVD)
- Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Ab (IgG/IgM) GICA Rapid Test Kit (Gold Colloidal Immunoassay) (CE-IVD)
- Shenzhen Bioeasy Biotechnology Co., Ltd WITHDRAWN – Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test
- Shenzhen GeneBioHealth Co., Ltd SARS-CoV-2 Nucleic Acid Test Kit (RT-PCR) (CE-IVD)
- Shenzhen GeneBioHealth Co., Ltd SARS-CoV-2 IgM IgG Test Kit (Colloidal Gold) (CE-IVD)
- Shenzhen LeafMed Technology Ltd Coronavirus COVID-19(SARS-CoV-2) IgM/IgG Rapid Test Kit (CE-IVD)
- Shenzhen Lifotronic Tech. Co., Ltd SARS-CoV-2 Nucleic Acid Detection Kit (CE-IVD)
- Shenzhen Lvshiyuan Biotechnology Co., Ltd Green Spring Flu A & Flu B & COVID-19 Ag Rapid Test (CE-IVD)
- Shenzhen Lvshiyuan Biotechnology Co., Ltd Green Spring SARS-CoV-2 Antigen Rapid Test Kit (CE-IVD)
- Shenzhen Lvshiyuan Biotechnology Co., Ltd Green Spring COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit (Brazil ANVISA - Philippines FDA - Russia RZN - CE-IVD)
- Shenzhen Microprofit Biotech Co., Ltd SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay) (CE-IVD)
- Shenzhen Microprofit Biotech Co., Ltd SARS-CoV-2 IgG & IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) (CE-IVD)
- Shenzhen Microprofit Biotech Co., Ltd SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (CE-IVD)
- Shenzhen Microprofit Biotech Co., Ltd SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit (Colloidal Gold) (CE-IVD)
- Shenzhen Microprofit Biotech Co., Ltd SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold) (CE-IVD)
- Shenzhen Microprofit Biotech Co., Ltd SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) (CE-IVD)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA) (CE-IVD)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) (CE-IVD)
- Shenzhen Puruikang Biotech Co., Ltd Detection Kit for 2019-Novel Coronavirus RNA (RT-PCR-Fluorescence Probing) (CE-IVD)
- Shenzhen Render Bio-tech Co., Ltd. COVID-19 IgM & IgG Test (Immunochromatography) (CE-IVD)
- Shenzhen Shineway Technology Corp. SARS-CoV-02 PCR Testing Kit (RUO)
- Shenzhen Tailored Medical Ltd New Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (CE-IVD)
- Shenzhen Tailored Medical Ltd Novel Coronavirus (SARS-CoV-2) IgM/IgG Antibody Assay Kit (Colloidal Gold Method) (CE-IVD)
- Shenzhen UD-Bio Co., Ltd SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgM (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd Unicell-2019-nCoV NAb (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd Unicell-2019-nCoV Ag (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd GLINE-2019-nCoV Ag (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd GLINE-2019-nCoV IgA (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd GLINE-2019-nCoV IgM/IgG (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash 2019-nCoV IgA (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash-2019-nCoV Antigen (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgG (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash 2019-nCoV NAb (CE-IVD)
- Shenzhen Zhenrui Biotech Co., Ltd COVID-19 IgGg/IgM Rapid Test Cassette (WB/S/P) (CE-IVD)
- Sherlock Biosciences Sherlock™ CRISPR SARS-CoV-2 (US FDA EUA)
- Shimadzu Corp. 2019 Novel Coronavirus Detection Kit (RUO)
- Sichuan Xincheng Biological Co., Ltd SARS-Cov-2 IgG/M Antibody Assay Kit by Immunofluorescence Chromatography Method (CE-IVD)
- Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV‑2 Total (COV2T) (US FDA EUA - Australia TGA - Singapore HSA - Health Canada)
- Siemens Healthineers Atellica®IM SARS-CoV-2 Total (COV2T) (US FDA EUA - Canada Health - Australia TGA - Singapore HSA - CE-IVD)
- Siemens Healthineers CLINTEST Rapid COVID-19 Antigen Test (CE-IVD)
- SignalChem Biotech Inc. 2019-nCoV S1 Human IgG ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV S1 Human IgA ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV S1 Human IgG-IgA-IgM ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV Neutralization ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV N-S1 Human IgM ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV N-S1 Human IgG-IgA-IgM ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV N-S1 Human IgA ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV S1 Human IgM ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV High Sensitivity S1 Protein ELISA Kit (RUO)
- SignalChem Biotech Inc. 2019-nCoV S1 Protein ELISA Kit (RUO)
- SignalDT Biotechnologies (SZ), Inc. LyoDx® A Freeze-Dried Real-Time RT-PCR Detection Reagent for SARS-CoV-2 (In development)
- SkillCell EasyCOV (CE-IVD)
- SLS Bio Co. Ltd SsmarTest COVID-19 IgM/IgG Detection Kit (Korea MFDS EUA - CE-IVD)
- Snibe Co., Ltd (Shenzhen New Industries Biomedical Engineering Co., Ltd) MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) (CE-IVD)
- Snibe Co., Ltd (Shenzhen New Industries Biomedical Engineering Co., Ltd) MAGLUMI 2019-nCoV IgG (CLIA) (Brazil ANVISA - US FDA EUA - Singapore HSA - CE-IVD)
- Snibe Co., Ltd (Shenzhen New Industries Biomedical Engineering Co., Ltd) MAGLUMI 2019-nCoV IgM (CLIA) (Brazil ANVISA - US FDA EUA - Singapore HSA - CE-IVD)
- SNP Biotechnology R&D Ltd Co. COVID-19 Real Time PCR Kit (CE-IVD)
- Solgent Co.Ltd DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit (Korea MFDS EUA - US FDA EUA - Philippines FDA - Singapore HSA - CE-IVD)
- Sona Nanotech Sona-COVID-19 LFA (CE-IVD)
- Spectrum for Diagnostic Industries (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit (RUO)
- Spindiag GmbH Spindiag Rhonda SARS-CoV-2 test (CE-IVD)
- Spring Healthcare Services AG SARS-Cov-2 Antigen Rapid Test Cassette (Swab) (US FDA EUA - Brazil ANVISA - CE-IVD)
- Spring Healthcare Services AG COVID-19 IgG/IgM Rapid Test (colloidal gold-based) (CE-IVD)
- St. Petersburg Research Institute of Vaccines and Sera (FSUE SPbSRIVS FMBA) SARS-CoV-2 Tru-EIA (RUO)
- Star Array Pte Ltd 8-minute RT-qPCR direct PCR testing system for SARS-CoV-2 detection (RUO)
- STILLA COVID-19 Multiplex Crystal Digital PCR detection kit (In development)
- Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (manual) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgG (RDT) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (RDT) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgM (manual) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgM (RDT) (CE-IVD)
- Sure Bio-Tech (USA) Co., Ltd Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) (CE-IVD)
- Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgM Ab Rapid Test (CE-IVD)
- Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgM/IgG Ab Rapid Test (CE-IVD)
- Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgG Ab Rapid Test (CE-IVD)
- Sure Bio-Tech (USA) Co., Ltd 2019-nCoV Antigen Rapid Test (Colloidal Gold) (CE-IVD)
- SureScreen Diagnostics Ltd SureScreen COVID-19 Antigen Rapid Test Cassette (MHRA UK - CE-IVD)
- Suzhou BTA Biotech Co. Ltd Real time RT-PCR Kit for the detection of SARS-CoV-2 (China NMPA EUA)
- Suzhou Molarray Co. Ltd MA-6000 (China NMPA EUA - CE-IVD)
-
SVS Industries
Nasal Flock Swab
(validated ICMR)
- Syrona Limited COVID-19 IgG/IgM Rapid Test Cassette (CE-IVD)
- Systaaq Diagnostic Products 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit (CE-IVD)
- TaiDoc Technology Corporation FORA COVID-19 Antigen Rapid test (Taiwan FDA EUA - CE-IVD)
- TaiDoc Technology Corporation VTRUST COVID-19 Antigen Rapid test (Taiwan FDA EUA - CE-IVD)
- Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgG (CE-IVD)
- Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgM (CE-IVD)
- TargetingOne Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Digital PCR method) (RUO)
- Tauschen Int. Ltd (Tauschen Groups) COVID - 19 RAPID TEST KIT / Antibody IgG& IgM Test Kit (China NMPA EUA - CE-IVD)
- TECNO-BIOS SRL FAST-COVID-SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)
- TECOmedical AG / Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019-nCOV IgM Antibody kit (ELISA) (Philippines FDA - CE-IVD)
- TECOmedical AG / Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019-nCOV IgG Antibody kit (ELISA) (Philippines FDA - CE-IVD)
- Telepoint Medical Services LLC Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test (RUO)
- Tellgen Corporation SARS-CoV-2 Nucleic acids detection kit based on Real-Time PCR platform (CE-IVD - WHO EUL)
- TestLine Clinical Diagnostics Ltd Microblot-Array COVID-19 IgA / Microblot-Array COVID-19 IgG / Microblot-Array COVID-19 IgM (CE-IVD)
- TestLine Clinical Diagnostics Ltd SmartEIA COVID-19 NP IgA / SmartEIA COVID-19 NP IgG / SmartEIA COVID-19 NP IgM (CE-IVD)
- TestLine Clinical Diagnostics Ltd EIA COVID-19 NP IgA / EIA COVID-19 NP IgM / EIA COVID-19 NP IgG (CE-IVD)
- Tetracore Inc. Multiplex detection and differentiation SARS-Cov-2 Serology Assay (manual) (RUO)
- Tezted Oy SARSPLEX: Anti-SARS-CoV-2 IgM / IgG / IgA ELISA (measure individual Ig easily) (CE-IVD)
- Thermo Fisher Scientific TaqPath™ COVID-19 Combo Kit (US FDA EUA - Health Canada - Australia TGA - Singapore HSA - South Africa SAHPRA)
- Thermo Fisher Scientific TaqPath™ COVID-19 CE-IVD RT-PCR Kit (US FDA EUA - Health Canada - Australia TGA - Singapore HSA - South Africa SAHPRA - CE-IVD - WHO EUL)
- Thermo Fisher Scientific OmniPATH COVID-19 Total Antibody ELISA Test (US FDA EUA)
- Tianjin Era Biology Technology Co., Ltd COVID-19 IgM/IgG Lateral Flow Assay (CE-IVD)
- Tianjin Era Biology Technology Co., Ltd COVID-19 IgM Lateral Flow Assay (CE-IVD)
- Tianjin Era Biology Technology Co., Ltd COVID-19 IgG Lateral Flow Assay (CE-IVD)
- Tianjin Jianbo Biological Co., Ltd SARS-CoV-2 Specific IgM and IgG Test Kit (Coillodal Gold) (RUO)
- Tianjin MNCHIP Technologies Co., Ltd. Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) (CE-IVD)
- TIB Molbiol/Roche Diagnostics LightMix Modular SARS-CoV-2 (COVID19) N-gene (RUO)
- TIB Molbiol/Roche Diagnostics LightMix Modular SARS-CoV-2 (COVID19 RdRP-gene (Philippines FDA - RUO)
- TIB Molbiol/Roche Diagnostics LightMix Modular SARS-CoV-2 (COVID19) E-gene (Philippines FDA - RUO)
- Tody Laboratories Int. Coronavirus (SARS-CoV-2) Antigen-Nasopharyngeal Specimen (CE-IVD)
- Tody Laboratories Int. Coronavirus (SARS-CoV-2) Antigen Oral Fluid (CE-IVD)
- Tody Laboratories Int. 2019-nCoV IgG/IgM (CE-IVD)
- Tody Laboratories Int. Coronavirus (SARS-CoV 2) & Influenza A+B, Antigen, combo - Nasopharyngeal Specimen (CE-IVD)
- TransGen Biotech Co., Ltd SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR) (CE-IVD)
- Trax Management Services Inc. PhoenixDx 2019-CoV (US FDA EUA - Philippines FDA)
- Tridan/CBS Group ZEKMED COVID-19 IgG/IgM Rapid Test Device (Philippines FDA - SWISSMEDIC - CE-IVD)
- Trinity Biotech Bartels FlexTrans™ Medium (US FDA EUA)
- Trivitron Healthcare Pvt. Ltd NATSure COVID-19 SinglePlex Real-time PCR Kit (CE-IVD)
- Trivitron Healthcare Pvt. Ltd RNAsure RNA Extraction Kit (CE-IVD)
- Trivitron Healthcare Pvt. Ltd ViSure transport kit (CE-IVD)
- Twist Bioscience NGS-based target capture for SARS-CoV-2 detection and screening (In development)
- U2USystems (India) Pvt. Ltd 2019-ncoV IgG/IgM Test (CE-IVD)
- UDIBI - ENCB Instituto Politécnico Nacional UDITEST-V2G (COFEPRIS)
- Ukrgentech RT-PCR test kit for COVID-19 detection (CE-IVD)
- Ultrabio Technologies Inc. SARS-CoV-2 (ORF1ab/N) Nucleic Acid Detection Kit (RUO)
- University of Washington Tongue swab diagnosis of SARS-CoV-2 (In development)
- Ustar Biotechnologies (Hangzhou) Ltd EasyNAT Integrated, Automated Molecular Diagnostic Assay for COVID-19 RNA (Australia TGA - China NMPA EUA)
- Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test (US FDA EUA - Singapore HSA - Philippines FDA - CE-IVD)
- Veredus Laboratories Pte Ltd VereCoV™ OneMix Detection Kit (formerly VereCoV™ Detection Kit and VerePLEX™ Biosystem ) (Singapore HSA)
- Veredus Laboratories Pte Ltd VereRT™ COVID-19 PCR Kit (formerly VereRTCoV™ SARS-CoV-2 Real-Time RT-PCR 2.0) (Singapore HSA - Philippines FDA)
- Veredus Laboratories Pte Ltd VereRT™ ZeroPrep™ COVID-19 PCR Kit (formerly VereRTCoV™ 3.0 ZeroStep Real-Time RT-PCR) (Singapore HSA)
- Veredus Laboratories Pte Ltd ZeroPrep™ Saliva Collection Kit (Singapore HSA)
- Veredus Laboratories Pte Ltd Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19 (Singapore HSA - CE-IVD)
- Verify Diagnostics Inc. Covid-19 IgG/IgM Antibody Rapid Test (RUO)
- Viet A Technology Corporation LightPower iVASARS-CoV-2 1st RT-rPCR Kit (CE-IVD)
- Vircell S.L. COVID-19 ELISA IgG (CE-IVD)
- Vircell S.L. COVID-19 VIRCLIA® IgG MONOTEST (CE-IVD)
- Vircell S.L. COVID-19 VIRCLIA® IgM+IgA MONOTEST (CE-IVD)
- Vircell S.L. COVID-19 ELISA IgM+IgA (CE-IVD)
- Vircell, S.L. SARS-COV-2 REALTIME PCR KIT (Brazil ANVISA - CE-IVD)
- Visible Patient Visible Patient Service - numerical (medical image analysis, CT or MRI) (US FDA 501(k) - CE Class IIa)
- Vision Biotechnology Research & Development VISION COVID19 Easyprep Test Kit (In development)
- Vitassay Healthcare S.L. Vitassay qPCR SARS-CoV-2 (CE-IVD)
- Vitro SA SARS-CoV-2 RT-PCR (CE-IVD)
- Vitrosens Biyoteknoloji Ltd. Şti. Rapidfor SARS-CoV-2 Ag Test Kit (CE-IVD)
- VivaChek Biotech (Hangzhou) Co., Ltd VivaDiag COVID-19 IgM/IgG Rapid Test (Australia TGA - India CDSCO - Singapore HSA - CE-IVD)
- Vivantis Technologies Sdn Bhd ViPrimePLUS 2019-nCoV Multiplex RT-qPCR Kit (CE-IVD)
- Wells Bio, Inc. careUS™ COVID-19 IgM/IgG (In development)
- Wells Bio, Inc. careGENE™ N-CoV RT-PCR kit (Korea MFDS EUA - Brazil ANVISA - CE-IVD)
- Wells Bio, Inc. careGENE™ COVID-19 RT-PCR kit (Korea MFDS EUA - CE-IVD)
- WESAIL Biotech Inc. WESAIL COVID-19 IgM IgG Antibody Test Kit (CE-IVD)
- WESAIL Biotech Inc. WESAIL COVID-19 Antigen Test Kit (CE-IVD)
- Willi Fox GmbH Willi Fox COVID-19 Antigen rapid test (CE-IVD)
- Willi Fox GmbH Willi Fox Covid-19 IgM/ IgG rapid test (CE-IVD)
- Wizbiosolutions Inc. WizDx™ COVID-19 Real-time PCR Kit (Korea MFDS EUA - CE-IVD)
- Wizbiosolutions Inc. WizDx™ COVID-19 CrystalMix PCR Kit (Korea MFDS EUA - CE-IVD)
- Wuhan Easydiagnosis Biomedicine Co., Ltd COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit (China NMPA EUA - Australia TGA - South Africa SAHPRA - Philippines FDA - CE-IVD)
- Wuhan EasyDiagnosis Biomedicine Co., Ltd Novel Coronavirus IgG antibody test kit (colloidal gold method) (Australia TGA - Brazil ANVISA - CE-IVD)
- Wuhan EasyDiagnosis Biomedicine Co., Ltd Novel Coronavirus IgM antibody test kit (colloidal gold method) (Australia TGA - Brazil ANVISA - CE-IVD)
- Wuhan HealthCare Biotechnology Co., Ltd Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit (CE-IVD)
- Wuhan UNscience Biotechnology Co., Ltd Covid-19 IgG/IgM Antibody Rapid Test Kit (Brazil ANVISA - CE-IVD)
- Wuxi Shenrui Bio-pharmaceuticals Co. Ltd Covflu-SR, Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection (In development)
- Xi'an Goldmag Nanobio Tech Co., Ltd Real-Time RT-PCR assays for the detection of SARS-CoV-2 (CE-IVD)
- Xiamen AmonMed Biotechnology Co., Ltd COVID-19 Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)
- Xiamen Biotime Biotechnology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit (US FDA EUA - CE-IVD)
- Xiamen Boson Biotech Co. Ltd Rapid 2019-nCoV IgG/IgM Combo Test Card (Singapore HSA - CE-IVD)
- Xiamen Boson Biotech Co. Ltd Rapid SARS-CoV-2 Antigen Test Card (CE-IVD)
- Xiamen Wiz Biotech Co. Ltd SARS-CoV-2/Influenza A/Influenza B Antigen Rapid Test (CE-IVD)
- Xiamen Wiz Biotech Co. Ltd Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 (CE-IVD)
- Xiamen Wiz Biotech Co. Ltd SARS-CoV-2 Antigen Rapid Test (CE-IVD)
- Xiamen Zeesan Biotech Co., Ltd. SARS-CoV-2 Test Kit (Real-time PCR) (US FDA EUA - CE-IVD)
- Xi’an Tianlong Science and Technology Co., Ltd COVID-19 ORF1ab/N Gene PCR Detection Kit (RUO)
- Xpedite Diagnostics GmbH SwiftX Swabs (Covid19 RNA extraction kit) (CE-IVD)
- Yaneng BIOscience (Shenzhen) Co., Ltd COVID-19 Nucleic Acid Detection Kit (Multiplex Real Time PCR) (RUO)
- YD Diagnostics Corp. MolecuTech® Real-Time COVID-19 (CE-IVD)
- YouSeq Ltd YouSeq SARS-COV-2 qPCR Test (RUO)
- Yuno Diagnostics Co., Ltd Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits (CE-IVD)
- Z BIOTECH INC. AnyLab COVID-19 Ag Test Kit (CE-IVD)
- Zalgen Labs, LLC ReSARS Pan-Corona Rapid Test (In development)
- Zalgen Labs, LLC ReSARS Pan-Corona IgM ELISA Kit (In development)
- Zalgen Labs, LLC ReSARS Pan-Corona Antigen ELISA Kit (In development)
- Zalgen Labs, LLC ReSARS CoV-2 IgM ELISA Kit (In development)
- Zalgen Labs, LLC ReSARS CoV-2 Antigen Rapid Test (In development)
- Zalgen Labs, LLC ReSARS CoV-2 Antigen ELISA Kit (In development)
- Zenostic Co., Ltd FastProof GoPlus SARS-CoV-2 RT-LAMP Kit (FDA Thailand - CE-IVD)
- Zenostic Co., Ltd FastProof Dual SARS-CoV-2 RT-LAMP Kit (FDA Thailand - CE-IVD)
- ZenTech SA QuickZen COVID-19 IgM / IgG (IVD-D)
- Zephyr Biomedicals-Tulip Group COVISCREEN–Rapid double antigen screening test for detection of IgM/IgG/IgA antibodies to COVID-19 in human serum/plasma/whole blood (India CDSCO - CE-IVD)
- Zhejiang Anji Saianfu Biotech Co., Ltd COVID-19 Antigen Rapid Test (Colloidal Gold) (CE-IVD)
- Zhejiang Gene Science Co., Ltd Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (CE-IVD)
- Zhejiang Orient Gene Biotech COVID-19 IgG/IgM Rapid Test (South Africa SAHPRA - Australia TGA - CE-IVD)
- Zhengzhou Humanwell Biocell Biotechnology Co., Ltd BIOCELL COVID-19 IgG ELISA test (CE-IVD)
- Zhengzhou Humanwell Biocell Biotechnology Co., Ltd BIOCELL COVID-19 IgM ELISA test (CE-IVD)
- Zhuhai Haitai Biological Pharmaceutical Co., Ltd Novel Coronavirus (2019-nCoV)/Flu A/Flu B Real-time Multiplex RT-PCR Kit (manual & automated lab-based) (RUO)
- Zhuhai Lituo Biotechnology Co., Ltd COVID-19 Antigen Detection Kit (Immunofluorescence Assay) (CE-IVD)
- Zhuhai Lituo Biotechnology Co., Ltd COVID-19 Antigen Detection Kit (Colloidal Gold) (CE-IVD)
- Zhuhai Livzon Diagnostics Inc. Diagnostic Kit for IgM Antibody to Corona Virus (nCoV-2019) (Colloidal Gold) (China NMPA EUA - Australia TGA - CE-IVD)
- Zhuhai Livzon Diagnostics Inc. Diagnostic Kit for Nucleic Acid to nCoV-2019 (PCR- Fluorescence Probe) (RUO)
- Zugotech Labs Ltd Zugotech COVID-19 IgM/IgG Rapid Test (In development)
- Zybio Inc. SARS-CoV-2 IgM and IgG Antibody Assay Kit (CE-IVD)
- Zybio, Inc. SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) (Philippines FDA - CE-IVD)
- Zymo Research Corp. Quick COVID-19 Antibody Detection Kit (RUO)
- Zymo Research Corp. Quick SARS-CoV-2 Multiplex Kit (CE-IVD)
- Zymo Research Corp. Quick SARS-CoV-2 rRT-PCR Kit (US FDA EUA - CE-IVD)
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