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. We do not guarantee that this is a comprehensive list, since the information below has been 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.
If you would like your test to be included in the pipeline, please click on this button to download the form. Submission form
To know more about the FIND evaluations of submitted SARS-CoV-2 tests, click here. ongoing test evaluations
EUA: Emergency Use Authorization — HSA: Health & Safety/Sciences Authority — MFDS: Ministry of Food & Drug Safety — MoH: Ministry of Health — MHRA: Medicines & Health Care Products Regulatory Agency — NRA: National Regulatory Authority — RUO: Research Use Only — TGA: Therapeutic Goods Administration — WHO EUL: World Health Organization Emergency Use Listing
- 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-SARS-CoV-2 (CE-IVD)
- AB ANALITICA srl REALQUALITY RQ-2019-nCoV (CE-IVD)
- Abace Biotechnology COVID-19 IgG / IgM Antibody Test Kit (CE-IVD)
- Abace Biotechnology Virus Sampling 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 Abbott Architect SARS-CoV-2 IgG (US FDA EUA - Singapore HSA - Health Canada - CE-IVD)
- Abbott Laboratories SARS-CoV-2 IgM Kit (Australia TGA)
- 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)
- 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)
- 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 COVID-19 RAPID IgG/IgM test kit (CE-IVD)
- Accuster Technologies Pvt Ltd Accuster SARS-COV2-RT-PCR test kit (CE-IVD)
- Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 Antigen Rapid Test (CE-IVD)
- Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test (CE-IVD)
- Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 RT-PCR Test Kit (CE-IVD)
- ACRO Biotech Inc. Família Teste Rápido em Cassete 2019-nCoV IgG/IgM (Brazil ANVISA)
- Acumen Research Laboratories Pte Ltd Acu-Corona 2.0 (Singapore HSA)
- Acumen Research Laboratories Pte Ltd Acu-Corona (RUO)
- 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)
- Advanced Biological Laboratories SA UltraGene Combo2Screen SARS-CoV-2 Assay (South Africa SAHPRA - CE-IVD)
- Advanced Molecular Diagnostics Zena Max – SARS-COV-2 Direct q-PCR Detection Kit (CE-IVD)
- Advanced Molecular Diagnostics Zena Max – SARS-COV-2 Real Time 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)
- 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 IgM (CE-IVD)
- AMEDA Labordiagnostik GmbH AMP ELISA Test SARS-CoV-2 IgG (CE-IVD)
- AMEDA Labordiagnostik GmbH AMP ELISA Test SARS-CoV-2 Ab (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 IgM/IgG test kit (Colloidal Gold) (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)
- 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 IgM ELISA (CE-IVD)
- AMS UK Ltd COVID-19 Lyophilised Nucleic Acid Kit (CE-IVD)
- AMS UK Ltd COVID-19 ELISA (total antibody) (CE-IVD)
- AMS UK Ltd COVID-19 IgG ELISA (CE-IVD)
- AMS UK Ltd COVID-19 Antigen ELISA (CE-IVD)
- AMS UK Ltd 2019-nCoV IgG/IgM Device (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 Deep Blue Medical Technology Co., Ltd COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (CE-IVD)
- Anhui Deep Blue Medical Technology Co., Ltd Colloidal gold strip for SARS-CoV-2 IgG & IgM (RUO)
- AniCon Labor GmbH Kylt® SARS-CoV-2 Confirmation RT-qPCR (CE-IVD)
- AniCon Labor GmbH Kylt® SARS-CoV-2 Screening RTU RT-qPCR (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 IgM ELISA (CE-IVD)
- Ansh Labs SARS-CoV2 IgG ELISA (CE-IVD)
- AnyGenes Efficient 2019-nCOV detection kit, one step RT-qPCR (N1 & N2) (RUO)
- Apollo Biomedical LLC Novel SARS-CoV-2 Coronavirus/MERS-CoV/Influenza Virus A/B Multiple Antigen Detection Kit (RUO)
- Apollo Biomedical LLC Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) (MHRA UK - CE-IVD)
- Applied BioCode Inc. BioCode SARS-CoV-2 Assay (US FDA EUA)
- Applied Biological Materials Inc. Sample Collection and Viral Transport Solution (CE-IVD)
- Applied Biological Materials Inc. GenomeCoV19 Detection Kit (CE-IVD)
- Applied Biological Materials Inc. GenomeCov19 IgM/IgG Rapid Test Kit (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)
- 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 (Brazil ANVISA)
- Asan Pharmaceutical Co. Ltd Asan Easy Teste Covid-19 IgG/IgM (Brazil ANVISA)
- 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)
- Atlas Medical Atlas COVID-19 S1-RBD IgG Elisa Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 IgG/IgM Test Cassette (CE-IVD)
- Atlas Medical Atlas COVID-19 Real Time RT-PCR Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 IgM Elisa Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 Total Antibody Elisa Kit (CE-IVD)
- Atlaslink Beijing Technology Co., Ltd NOVA Test® COVID-19 IgG/IgM Antibody Test (Colloidal Gold) (Australia TGA)
- Augurix SA Simtomax Corona Check IgM/IgG Rapid COVID 19 test (CE-IVD)
- 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)
- 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 SARS-FluA/B-RSV (RUO)
- BAG Diagnostics GmbH ViroQ SARS-CoV-2 (CE-IVD)
- BAG Diagnostics GmbH ViroQ Rapid SARS-CoV-2 (CE-IVD)
- Bai-care (Tianjin) Biotechnology Co., Ltd Multiplex Nucleic Acid Detection Kit for Respiratory Pathogens (CE-IVD)
- 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 Antibody (IgG/IgM)Test Kit (Colloidal Gold Immunochromatography) (India CDSCO - CE-IVD)
- Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen 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 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 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 Fully Automated 26 Plex RES Panel Assay (RUO)
- Beijing Bohui Innovation Biotechnology Automated SarS-CoV-2 NAT (RUO)
- Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgM 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 IgG 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) Antibody 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 (Up-converting Phosphor Technology) (CE-IVD)
- 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) Nucleic Acid Test Kit (PCR-Fluorescent Probe Method) (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/IgM Rapid Test Kit (Fluorescence) (CE-IVD)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Nucleic Acid Test Kit (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 ELISA Test Kit (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 Antigen 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 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 Combo IgM/IgG Rapid Test (Lateral Flow Method) (India CDSCO - CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Antigen Saliva Rapid Test (CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Antigen Rapid Test (CE-IVD)
- Beijing Tigsun Diagnostics Co., Ltd Tigsun COVID-19 Antigen Rapid Test (FIA) (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 RT-PCR Kit (RUO - WHO EUL)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 Ab Rapid Test (Australia TGA)
- Beijing Wantai Biological Pharmacy Enterprise Co., Ltd Wantai SARS-CoV-2 Ab ELISA (CE-IVD)
- BGI Health Co. Ltd SARS-CoV-2 Virus IgM Antibody Detection Kit (ELISA) (CE-IVD)
- BGI Health Co. Ltd SARS-CoV-2 Virus IgG Antibody Detection Kit (ELISA) (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 IgM/IgG rapid assay kit (Colloidal Gold) (CE-IVD)
- Bio Basic Canada Inc. SARS-CoV-2 RT-PCR Detection Kit (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)
- 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 Rapid Test Kit (Fluorescence Immunochromatography) (CE-IVD)
- BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 Antigen quantitative assay kit (Enzyme-linked immunoassay) (Australia TGA - Brazil ANVISA - CE-IVD)
- BioLab Sciences COVID-19 Rapid IgM/IgG Antibody Test Kit (RUO)
- Biolidics Ltd 2019-nCoV IgG/IgM Antibody Detection Kit (Singapore HSA - CE-IVD)
- bioLytical Laboratories Inc. INSTI COVID-19 Self Test (RUO)
- bioLytical Laboratories Inc. INSTI SARS-CoV2 Total Antibody Test (RUO)
- BioMaxima S.A. 2019-nCoV IgG/IgM Rapid Test Cassette (India CDSCO - CE-IVD)
- BioMaxima S.A. COVID-19 Antigen Rapid Test (CE-IVD)
- BioMaxima S.A. SARS-CoV-2 Real Time PCR LAB-KIT™ (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 423720) (CE-IVD)
- bioMérieux SA SARS-COV-2 R-GENE® (ref 423735) (US FDA EUA - South Africa SAHPRA - Philippines FDA - Brazil ANVISA)
- bioMérieux SA SARS-COV-2 R-GENE® (ref 423717) (RUO)
- bioMérieux SA VIDAS SARS-CoV-2 IgG & IgM (US FDA EUA - Philippines FDA)
- 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 SAS COVID19SEROSpeed-IgM-IgG (CE-IVD)
- Bioss Inc. SARS-Cov-2 IgM Antibody ELISA Kit (RUO)
- Bioss Inc. SARS-Cov-2 Total Antibody ELISA Kit (RUO)
- Bioss Inc. SARS-Cov-2 Nucleoprotein ELISA Kit (RUO)
- BIOSYNEX SWISS SA BIOSYNEX COVID-19 Ag BSS (CE-IVD)
- BIOSYNEX SWISS SA BIOSYNEX COVID-19 BSS (Brazil ANVISA - Singapore HSA - CE-IVD)
- Biotech & Biomedicine (Shenyang) Group Ltd Real Time PCR Detection Kit For COVID-19 Coronavirus (CE-IVD)
- Biotech & Biomedicine (Shenyang) Group Ltd Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus (CE-IVD)
- BIOTECON Diagnostics GmbH virusproof SL SARS-CoV-2 Real-time PCR Kit (RUO)
- BIOTECON Diagnostics GmbH Acu-CoronaTM 2.0/3.0 SARS-CoV-2 Real-time PCR Kits (Philippines FDA - RUO)
- BIOTECON Diagnostics GmbH microproof SARS-CoV-2 Screening/Identification Kits (RUO)
- BioTNS Co. Ltd COVID-19 RT-PCR PNA KIT (US FDA EUA - Korea MFDS EUA - Philippines FDA - CE-IVD)
- Blue Cross Bio-Medical (Beijing) Co., Ltd One Step Novel Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (CE-IVD)
- BluSense Diagnostics ApS ViroTrack COVID IgA+IgM/IgG/Total Ig Ab (CE-IVD)
- Boditech Inc. ExAmplar COVID-19 real-time PCR kit (L) (RUO)
- Boditech Inc. Ichroma COVID-19, viral antigen (manual) (RUO)
- Boditech Inc. AFIAS COVID-19 Ab, IgM/IgG (automated) (Brazil ANVISA - CE-IVD)
- Boditech Inc. NuActor – viral RNA extraction kit (Korea MFDS EUA - CE-IVD)
- Boditech Inc. AFIAS COVID-19, Viral Antigen (automated) (Philippines FDA - Brazil ANVISA - CE-IVD)
- Boditech Inc. Ichromia COVID-19 Ab, IgM/IgG (manual) (Brazil ANVISA - CE-IVD)
- BTNX Inc. Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)
- 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)
- 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)
- Cell ID Pte Ltd Smart COVID-19 IgM/IgG RDT (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 - 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 Real Time PCR Detection Kit (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 S gene Real Time PCR Detection Kit adapted for BD MAX™ System (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™ Coronavirus (Covid19) IgG & IgM Test (RUO)
- Confirm BioSciences Verasure™ COVID-19 Antigen Rapid Swab Test (RUO)
- Core Technology Co., Ltd COVID-19 IgM/IgG Ab Test (South Africa SAHPRA - CE-IVD)
-
Coris BioConcept
COVID-19 Ag Respi-Strip (CE-IVD)
(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) 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) Nucleoprotein Protein ELISA Kit (RUO)
- Creative Biolabs SARS-CoV-2 (2019-nCoV) Spike 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) Total Antibody Rapid Test Kit (RUO)
- Creative Diagnostics SARS-CoV-2 IgM ELISA Kit (RUO)
- Creative Diagnostics SARS-COV-2 Total Antibody ELISA Kit (RUO)
- Creative Diagnostics SARS-CoV-2 IgG ELISA Kit (RUO)
- Creative Diagnostics SARS-CoV-2 Antigen ELISA Kit (RUO)
- Credo Diagnostics Biomedical VitaPCR COVID-19 assay (Singapore HSA)
- CTK Biotech, Inc. OnSite™ COVID-19 IgG/IgM (Australia TGA - Brazil ANVISA - India CDSCO)
- CTK Biotech, Inc. Aridia COVID-19 Real Time PCR Test (Australia TGA - Philippines FDA - CE-IVD)
- 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)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgM ELISA (CE-IVD)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgG ELISA (CE-IVD)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgA ELISA (CE-IVD)
- Denka Co. Ltd QuickNavi-COVID19 Ag (Japan MHLW IVD)
- 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 COV19M.CE - ELISA COVID 19 IgM (CE-IVD)
- DIA.PRO Diagnostic BioProbes Srl COV19G.CE - ELISA COVID 19 IgG (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)
- DiaSorin Molecular, LLC Simplexa™ COVID-19 Direct RT-PCR Kit (US FDA EUA - CE-IVD - WHO EUL)
- DiaSorin SpA LIAISON®SARS-CoV-2 S1/S2 IgG (US FDA EUA - Health Canada - Brazil ANVISA - CE-IVD)
- DiaSorin SpA LIAISON®SARS-CoV-2 AG (CE-IVD)
- Diatech Pharmacogenetics EasyPGX® ready SARS-CoV-2 (CE-IVD)
- Diatech Pharmacogenetics Easy® SARS-CoV-2 (CE-IVD)
- Diatheva SRL COVID-19 PCR DIATHEVA Detection kit (CE-IVD)
- Diesse Diagnostica Senese SpA ELISA Enzywell SARS-CoV-2 IgA (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)
- 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)
- DRG International, Inc. COVID-19 lgG, EIA-6146 (CE-IVD)
- DRG International, Inc. COVID-19 lgM, EIA-6147 (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 A500 RT (CE-IVD)
- Elisabeth Pharmacon spol. s.r.o. EliGene® COVID19 BASIC A RT (CE-IVD)
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- 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 (IgA) (Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)
- EUROIMMUN AG EURORealTime SARS-CoV-2 (US FDA EUA - Australia TGA - South Africa SAHPRA - CE-IVD)
- EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG) (US FDA EUA - Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)
- EUROIMMUN AG Anti-SARS-CoV-2-NCP ELISA (IgG) (CE-IVD)
- Eurospital S.p.A. SARS-COV-2 IgG (CE-IVD)
- Finbiosoft Results Manager (automatic PCR interpretation software) (RUO)
- Fjord Diagnostics SDN BHD SEDIPREP COVID-19 (CE-IVD)
- Fjord Diagnostics SDN BHD Fjord - Viral Transport Medium (VTM, alcohol formulation) (Malaysia MDA - 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)
- GenBody, Inc. GenBody COVID-19 IgM/IgG (Australia TGA - Brazil ANVISA - CE-IVD)
- GenBody, Inc. GenBody COVID-19 Ag (CE-IVD)
- GenBody, Inc. GenBody FIA COVID-19 IgM/IgG (manual) (RUO)
- GenBody, Inc. GenBody COVID-19 IgM/IgG 3.0 (RUO)
- 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 Respiratory Pathogen Panel (RUO)
- GeneFirst Ltd The Novel Coronavirus (2019-nCoV) Nucleic Acid Test Kit (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. FRANKD (CE-IVD)
- GeneMe Sp. z.o.o. Advanced One Step FAST Covi19 KIT Two Genes Set (CE-IVD)
- geneOmbio Technologies Pvt. Ltd geneOmbio COVID-19 rt-LAMP test (RUO)
- GeneProof a.s. GeneProof SARS-CoV-2 PCR Kit (CE-IVD)
- GeneProof a.s. GeneProof SARS-CoV-2 Screening PCR Kit (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)
- General Biologicals Corporation GB SARS-CoV-2 Ab ELISA (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 RdRP (confirmation test) (CE-IVD)
- Generi Biotech s.r.o. gb SARS-CoV-2 N (confirmation test) (CE-IVD)
- Generi Biotech s.r.o. gb SARS-CoV-2 Multiplex (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)
- 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)
- 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 CLART COVID-19 (CE-IVD)
- Genomica Sau qCOVID-19 (CE-IVD)
- Genomictree, Inc. AccuraTect RT-qPCR SARS-CoV-2 (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. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) (Brazil ANVISA - Singapore HSA - 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 IgG xPOC (CE-IVD)
- GenSure Biotech Inc. GenSure™ COVID-19 Antigen Rapid Kit (REF: P2004) (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)
- 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)
- Goldsite Diagnostics Inc. SARS-CoV-2 IgG/IgM Kit (manual) (CE-IVD)
- Green Cross Medical Science Corp. GENEDIA W One COVID-19 IgM/IgG (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 COVID-19 Colorimetric LAMP premix kit (CE-IVD)
- Green Cross Medical Science Corp. GENEDIA W COVID-19 Ag (CE-IVD)
- GRiSP Xpert qDetect COVID-19 (RUO)
- Guangzhou Darui Biotechnology Co.,Ltd Novel Coronavirus 2019-nCoV IgM Antibody Detection Kit (Colloidal Gold 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) IgM Antibody Detection Kit (ELISA 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 HEAS BioTech Co., Ltd 2019 Novel Coronavirus (2019-nCoV) RNA ASSAY (PCR Fluorescent Probe Method) (RUO)
- 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 ( Oral Fluid) (RUO)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 Antigen Rapid Test (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 Antigen Rapid Test with Reader (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 Antigen Test cassette (FIA) (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 with Reader (CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 and Influenza A+B Antigen Combo Rapid Test (CE-IVD)
- 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 (Australia TGA - Brazil ANVISA - CE-IVD)
- 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 COVID-19 IgG/IgM Rapid Test Device (CE-IVD)
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd Extended ViralTrans, Extended EnteroTrans, Sampling & Transport System (CE-IVD)
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd Viral Transport Medium (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. Aptima SARS-CoV-2 Assay (US FDA EUA - Australia TGA - Singapore HSA - India CDSCO - Saudi FDA)
- Hologic Inc. Panther Fusion SARS-CoV-2 assay (US FDA EUA - Health Canada - Australia TGA)
- Humasis Humasis COVID-19 IgG/IgM Test (Korea MFDS EUA - Brazil ANVISA - CE-IVD)
- Humasis Humasis COVID-19/Flu Ag Combo Test (Korea MFDS EUA - 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)
- 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 IgM ELISA Kit (CE-IVD)
- Ideal Tashkhis Atieh Co. SARS-CoV-2 IgG ELISA Kit (CE-IVD)
- IMMY clarus SARS-CoV-2 Total Antibody EIA (CE-IVD)
- InBios International, Inc. InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit (US FDA EUA - RUO)
- Ingenetix ViroReal® Kit SARS-CoV-2 & SARS (CE-IVD)
- 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 IgM - ESR400M (RUO)
- Institut Virion Serion GmbH SERION ELISA agile SARS-CoV-2 IgG - ESR400G (CE-IVD)
- Institut Virion Serion GmbH SERION ELISA agile SARS-CoV-2 IgA - ESR400A (CE-IVD)
- 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)
- Intrasense SA Myrian Covid-19 (China NMPA EUA - US FDA EUA - CE-IVD)
- Jetta Labs LLP OZO India SARS-CoV2 (COVID-19) lgG/lgM Test (Colloidal Gold Method) (CE-IVD)
- Jetta Labs LLP OZO Simcere Novel Coronavirus (2019-NCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (CE-IVD)
- Jetta Labs LLP OZO Diamond SARS-CoV2 (COVID-19) lgG/lgM Test (Latex Method) (CE-IVD)
- Jiangsu Bioperfectus Technologies Co. Ltd PerfectLyo SARS-COV-2 Real Time PCR kit (RUO)
- Jiangsu Bioperfectus Technologies Co. Ltd PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit (CE-IVD)
- Jiangsu Bioperfectus Technologies Co. Ltd PerfectQ COVID-19 Coronavirus Real Time PCR Kit (Australia TGA - US FDA EUA - WHO EUL)
- Jiangsu Bioperfectus Technologies Co. Ltd PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (CE-IVD)
- Jiangsu Microdiag Biomedicine Technology Co., Ltd Novel coronavirus 2019-nCoV nucleic acid detection kit (rRT- PCR method) (RUO)
- Jiangsu Microdiag Biomedicine Technology Co., Ltd Detection of 2019 novel coronavirus (2019-nCoV) by LFD RT-RAA (RUO)
- 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 IgM/IgG Antibody Test (Colloidal Gold) (CE-IVD)
- Joinstar Biomedical Technology Co., Ltd SARS-CoV-2 /MERS-CoV/ Influenza A&B Antigen Rapid Test (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 (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)
- JOYSBIO (Tianjin) Biotechnology Co., Ltd COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (CE-IVD)
- 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 SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) ELISA (CE-IVD)
- KRISHGEN BioSystems Human SARS-CoV-2 (Covid-19) ELISA (RUO)
- KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test (CE-IVD)
- KRISHGEN BioSystems SARS-CoV-2 (Covid-19) Real-Time PCR Kit (as per CDC Atlanta guidelines) (CE-IVD)
- KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test (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) Spike Protein IgG ELISA (manual) (RUO)
- KRISHGEN BioSytems Human SARS-CoV-2 (Covid-19) Qualitative ELISA (RUO)
- Krosgen Biotech KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit (CE-IVD)
- 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)
- Labtest Diagnostica SA Anti COVID-19 IgG/IgM Rapid Test (Brazil ANVISA)
- 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 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 Antigen Rapid Test Device (CE-IVD)
- 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)
- 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)
- LumiQuick Diagnostics Inc. QuickProfile™ COVID-19 ANTIGEN Test (Brazil ANVISA - Philippines FDA - CE-IVD)
- LumiQuick Diagnostics Inc. Quicknostics® COVID-19 RT-PCR (Brazil ANVISA - CE-IVD)
- LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgG EIA Test (CE-IVD)
- LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgG/IgM Combo Test Card (Brazil ANVISA - CE-IVD)
- LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgM EIA Test (CE-IVD)
- LumiraDx UK Ltd LumiraDx SARS-CoV-2 Ag Test (US FDA EUA - CE-IVD)
- LumiraDx UK Ltd LumiraDx SARS-CoV-2 RNA STAR (US FDA EUA)
- 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)
- 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)
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Medigen Vaccine Biologics Corp.
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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)
- Meril Diagnostics Pvt Ltd Meril COVID-19 One-step RT-PCR Kit (India CDSCO)
- 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 SARS-CoV-2 (CE-IVD)
- Mikrogen GmbH ampliCube Coronavirus Panel (CE-IVD)
- Mobidiag Novodiag COVID-19 (CE-IVD)
- Mobidiag Amplidiag COVID-19 (CE-IVD)
- 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)
- 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)
- nal von minden GmbH NADAL® COVID-19 Ag (CE-IVD)
- nal von minden GmbH NADAL® COVID-19 IgG/IgM Test (243003N-25, 243002N-20, 243001N-10) (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 Vazyme Medical Technology Co., Ltd 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit (China NMPA EUA - CE-IVD)
- Nanjing Weiyun Biotechnology Co., Ltd SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (CE-IVD)
- Nano-Ditech Corporation Nano-Check COVID-19 IgG/IgM Antibody Test (CE-IVD)
- NanoBio Lab, A*STAR Research Entities Isothermal Exponential Amplification for COVID-19 Detection (RUO)
- NanoEntek Inc. En-swer COVID-19 RT-PCR Kit (Korea export - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 IgG/IgM Duo (Korea MFDS EUA - 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 IgG/IgM Rapid Test (Korea MFDS EUA - CE-IVD)
- NDFOS Co., Ltd ND COVID-19 Detection Kit (Korea MFDS EUA - CE-IVD)
- Neomedica d.o.o. NAISSA SARS COV-2 IgA/IgM/IgG (CE-IVD)
- 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)
- Nirmidas Biotech, Inc. Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit (RUO)
- Nirmidas Biotech, Inc. pGOLD COVID-19 IgG/IgM/IgA Microarray Test (RUO)
- Norgen Biotek Corp Swab Collection and Total Nucleic Acid Preservation System (68800) (RUO)
- Norgen Biotek Corp Total RNA Purification Kit Dx (Dx17200) (CE-IVD)
- Norgen Biotek Corp 2019-nCoV TaqMan RT-PCR Kit (RUO)
- Norgen Biotek Corp Saliva RNA Collection and Preservation Devices RU53800 (RUO)
- NovaTec Immundiagnostica GmbH GSD NovaPrime® SARS-CoV-2 (COVID-19) (CE-IVD)
- NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgM (CE-IVD)
- NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgA (CE-IVD)
- NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgG (CE-IVD)
- NTBio Diagnostics Inc. COVID-19 IgG/IgM Antibody Test Cassette (Australia TGA - CE-IVD)
- NZYTech NZY Viral RNA Isolation kit (RUO)
- NZYTech SARS-CoV-2 One-Step RT-PCR Kit, RUO (MD03191) (RUO)
- NZYTech SARS-CoV-2 One-Step RT-PCR Kit, CE-IVD (MD03201) (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)
- 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 IgM/IgG (CE-IVD)
- Pantest SA Pantest Coronavirus Ag (INFARMED - CE-IVD)
- Paragon Genomics Inc. CleanPlex SARS-CoV-2 Research and Surveillance NGS Panel (RUO)
- PathoFinder RealAccurate Quadruplex SARS-CoV2 PCR Kit (CE-IVD)
- PathoFinder RealAccurate Quadruplex Corona-plus PCR Kit (CE-IVD)
- PaxGen Bio Co. Ltd PaxView COVID-19 real time RT-PCR (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. LAMPIGEN COVID-19 RT LAMP Kit (Turkey MoH - CE-IVD)
- Pharmaline Saglik Hizmetleri Ticaret A.S. COVIDİGEN Multiplex COVID-19 qRT-PCR KIT (Turkey MoH - CE-IVD)
- Pishtaz Teb Diagnostics SARS-CoV-2 IgM ELISA Kit (CE-IVD)
- Pishtaz Teb Diagnostics SARS-CoV-2 IgG ELISA Kit (CE-IVD)
- Pishtaz Teb Diagnostics COVID-19 One-Step COVID-19 RT-PCR Kit (CE-IVD)
- PreciGenome LLC FastPlex Triplex SARS-CoV-2 detection kit (US FDA EUA - CE-IVD)
- Precision Biosensor, Inc. Exdia COVID-19 IgG/IgM (CE-IVD)
- Precision Biosensor, Inc. Exdia COVID-19 Ag (Korea export - CE-IVD)
- Precision Biosensor, Inc. PBCheck COVID-19 IgG/IgM (CE-IVD)
- PRIMA Lab S.A. PRIMA COVID-19 IgG/IgM Rapid Test (CE-IVD)
- PRIME4DIA Co., Ltd P4DETECT COVID-19 IgM/IgG (CE-IVD)
- PRIME4DIA Co., Ltd P4DETECT COVID-19 SAg (RUO)
- PRIME4DIA Co., Ltd P4DETECT COVID-19 Ag (RUO)
- Primerdesign Ltd genesig Real-Time PCR COVID-19 (US FDA EUA - Singapore HSA - CE-IVD)
- PrivaPath Diagnostics, Inc. LetsGetChecked Coronavirus (COVID-19) Test (US FDA EUA)
- Progenie Molecular S.L.U. RealCycler CORO (CE-IVD)
- ProGnosis Biotech Rapid test 2019-nCoV IgM/IgG (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 IgM (CE-IVD)
- ProGnosis Biotech Bio-Shield 2019-nCoV Total Immunoglobulins (IgA, IgG, IgM) (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 DROP-TECH (CE-IVD)
- ProteomeTech Inc. KOVIcheck COVID-19 IgG/IgM (CE-IVD)
- ProteomeTech Inc. GENEdania COVID-19 qRT-PCR (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)
- Quick Energy Technologies Limited MediKit Covid-19 Antibody Test (IgM/IgG Lateral flow Immunoassay) (CE-IVD)
- Quidel Lyra SARS-CoV-2 Assay (US FDA EUA - Health Canada - CE-IVD)
- Quidel Sofia 2 SARS Antigen FIA (US FDA EUA)
- Quidel Sofia 2 Flu + SARS Antigen FIA (US FDA EUA)
- 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 IgG+IgM Duo (CE-IVD)
- RapiGEN Inc. BIOCREDIT COVID-19 IgG (RUO)
- RapiGEN Inc. BIOCREDIT COVID-19 Ag (Brazil ANVISA - Philippines FDA - CE-IVD)
- RayBiotech Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) (CE-IVD)
- Redcliffe Bioscience SARS – CoV2 lgG ELISA SARS & CoV2 lgM ELISA (µ-Capture) (CE-IVD)
- Redcliffe Bioscience Redcliffe Bioscience LightPower iVA-SARS-COV-2 One Step RT-rPCR KIT (Vietnam MoH - CE-IVD)
- 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)
- RPC Diagnostic Systems Anti-SARS-CoV-2 Enzyme immunoassay for the detection of 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)
- ScheBo Biotech AG ScheBo SARS-CoV-2 Quick (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)
- 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 E COVID-19 Total Antibody Test (RUO)
- SD BIOSENSOR, Inc. STANDARD F COVID-19 Ag FIA (Brazil ANVISA - CE-IVD)
- SD BIOSENSOR, Inc. STANDARD Q COVID-19 IgM/IgG Duo Test (Brazil ANVISA - CE-IVD)
-
SD BIOSENSOR, Inc.
STANDARD Q COVID-19 Ag Test (South Africa SAHPRA - Brazil ANVISA - CE-IVD - WHO EUL)
(validated ICMR)
- SEASUN BIOMATERIALS U-TOP™ COVID-19 Detection Kit (US FDA EUA - Korea MFDS EUA - Singapore HSA - China NMPA EUA - CE-IVD)
- SEASUN BIOMATERIALS AQ-TOP™ COVID-19 Rapid Detection Kit (US FDA 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)
- Sengenics Corporation Pte Ltd ImmuSAFE™ COVID Protein Microarray (RUO)
- Sengenics Corporation Pte Ltd ImmuSAFE™ COVID+ Protein Microarray (RUO)
- Sengenics Corporation Pte Ltd ImmuSAFE™ Respiratory Virus Protein Microarray (RUO)
- SensingSelf, Pte, Ltd S1 COVID-19 Rapid Antigen Test (CE-IVD)
- SensingSelf, Pte, Ltd S4 - Multiplex Rapid Antigen Test - COVID-19/MERS/Influenza A/Influenza B (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)
- 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 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd Covid-19 Antigen Rapid Test (Colloidal gold) (RUO)
- 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)
- 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 Bioeasy 2019-nCoV Total Ab GICA Rapid Test (CE-IVD)
- Shenzhen GeneBioHealth Co., Ltd SARS-CoV-2 IgM IgG Test Kit (Colloidal Gold) (CE-IVD)
- Shenzhen GeneBioHealth Co., Ltd SARS-CoV-2 Nucleic Acid Test Kit (RT-PCR) (CE-IVD)
- Shenzhen LeafMed Technology Ltd Coronavirus COVID-19(SARS-CoV-2) IgM/IgG Rapid Test Kit (CE-IVD)
- Shenzhen Lvshiyuan Biotechnology Co., Ltd Greenspring® COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit (CE-IVD)
- Shenzhen Microprofit Biotech Co., Ltd SARS-CoV-2 IgG & IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic 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 Yhlo Biotech Co. Ltd iFlash-2019-nCoV Antigen (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd GLINE-2019-nCoV IgA (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgM (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd GLINE-2019-nCoV IgM/IgG (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd Unicell-2019-nCoV Ag (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash 2019-nCoV IgA (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgG (CE-IVD)
- Shenzhen Zhenrui Biotech Co., Ltd COVID-19 IgGg/IgM Rapid Test Cassette (WB/S/P) (CE-IVD)
- 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 CLINTEST Rapid COVID-19 Antigen Test (CE-IVD)
- Siemens Healthineers Atellica®IM SARS-CoV-2 Total (COV2T) (US FDA EUA - Canada Health - Australia TGA - Singapore HSA - CE-IVD)
- 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 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)
- Snibe Co., Ltd (Shenzhen New Industries Biomedical Engineering Co., Ltd) MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) (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)
- Spectrum for Diagnostic Industries (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit (RUO)
- 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)
- Sugentech, Inc. SGTi-flex COVID-19 IgM (manual) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgM (RDT) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (manual) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (RDT) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgG (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 2019-nCoV Antigen Rapid Test (Colloidal Gold) (CE-IVD)
- Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgG 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 IgM Ab Rapid Test (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)
-
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)
- Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgM (CE-IVD)
- Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgG (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)
- TECOmedical AG / Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019-nCOV IgG Antibody kit (ELISA) (Philippines FDA - CE-IVD)
- TECOmedical AG / Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019-nCOV IgM 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 SmartEIA COVID-19 NP IgA / SmartEIA COVID-19 NP IgG / SmartEIA COVID-19 NP IgM (CE-IVD)
- 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 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 OmniPATH COVID-19 Total Antibody ELISA Test (US FDA EUA)
- 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)
- Tianjin Era Biology Technology Co., Ltd COVID-19 IgM/IgG Lateral Flow Assay (CE-IVD)
- Tianjin Era Biology Technology Co., Ltd COVID-19 IgG Lateral Flow Assay (CE-IVD)
- Tianjin Era Biology Technology Co., Ltd COVID-19 IgM 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 RdRP-gene (Philippines FDA - RUO)
- TIB Molbiol/Roche Diagnostics LightMix Modular SARS-CoV-2 (COVID19) E-gene (Philippines FDA - RUO)
- TIB Molbiol/Roche Diagnostics LightMix Modular SARS-CoV-2 (COVID19) N-gene (RUO)
- 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 ViSure transport kit (CE-IVD)
- Trivitron Healthcare Pvt. Ltd RNAsure RNA Extraction Kit (CE-IVD)
- Trivitron Healthcare Pvt. Ltd NATSure COVID-19 SinglePlex Real-time PCR Kit (CE-IVD)
- U2USystems (India) Pvt. Ltd 2019-ncoV IgG/IgM Test (CE-IVD)
- Ukrgentech RT-PCR test kit for COVID-19 detection (CE-IVD)
- Ultrabio Technologies Inc. SARS-CoV-2 (ORF1ab/N) Nucleic Acid Detection Kit (RUO)
- 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 Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19 (Singapore HSA - CE-IVD)
- Veredus Laboratories Pte Ltd ZeroPrep™ Saliva Collection Kit (Singapore HSA)
- 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 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. COVID-19 ELISA IgG (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)
- Vitassay Healthcare S.L. Vitassay qPCR SARS-CoV-2 (CE-IVD)
- Vitro SA SARS-CoV-2 RT-PCR (CE-IVD)
- VivaChek Biotech (Hangzhou) Co., Ltd VivaDiag COVID-19 IgM/IgG Rapid Test (Australia TGA - India CDSCO - Singapore HSA - CE-IVD)
- Wells Bio, Inc. careGENE™ COVID-19 RT-PCR kit (Korea MFDS EUA - CE-IVD)
- Wells Bio, Inc. careGENE™ N-CoV RT-PCR kit (Korea MFDS EUA - Brazil ANVISA - CE-IVD)
- WESAIL Biotech Inc. WESAIL COVID-19 IgM IgG Antibody Test Kit (CE-IVD)
- Willi Fox GmbH Willi Fox Covid-19 IgM/ IgG rapid test (CE-IVD)
- Willi Fox GmbH Willi Fox COVID-19 Antigen 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 Novel Coronavirus IgM antibody test kit (colloidal gold method) (Australia TGA - Brazil ANVISA - 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 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)
- 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 SARS-CoV-2 Antigen Test Card (CE-IVD)
- Xiamen Boson Biotech Co. Ltd Rapid 2019-nCoV IgG/IgM Combo Test Card (Singapore HSA - CE-IVD)
- Xiamen Wiz Biotech Co. Ltd Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 (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)
- 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)
- Zentech SA QuickZen COVID-19 IgM / IgG (RUO)
- 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 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 IgM ELISA test (CE-IVD)
- Zhengzhou Humanwell Biocell Biotechnology Co., Ltd BIOCELL COVID-19 IgG 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)
- 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 rRT-PCR Kit (US FDA EUA - CE-IVD)