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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489 Result(s)
- AAZ-LMB COVID-PRESTO® (CE-IVD)
- AB Dianostic Systems GmbH abia SARS-CoV-2 IgG/IgM (CE-IVD)
- Abace Biotechnology COVID-19 IgG / IgM Antibody Test Kit (CE-IVD)
- Abbott Diagnostics Panbio™ COVID-19 IgG/IgM Rapid Test Device (CE-IVD)
- Abbott Laboratories Abbott Architect SARS-CoV-2 IgG (US FDA EUA - Singapore HSA - Health Canada - CE-IVD)
- 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)
- Acon Biotech (Hangzhou) Co., Ltd SARS-CoV-2 Antigen FIA (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 Laboratories, Inc. Flowflex™ SARS-CoV-2 Antigen Rapid Test (CE-IVD)
- ACON Laboratories, Inc. ACON® COVID-19 IgG/IgM Rapid Test (US FDA EUA - CE-IVD)
- ACRO BIOTECH Inc. COVID-19 Antigen Rapid Test with Reader (CE-IVD)
- ACRO BIOTECH Inc. COVID-19 Antigen Rapid Test (Brazil ANVISA - CE-IVD)
- ACRO BIOTECH Inc. COVID-19 and Influenza A+B Antigen Combo Rapid Test with Reader (CE-IVD)
- ACRO BIOTECH Inc. COVID-19 and Influenza A+B Antigen Combo Rapid Test (CE-IVD)
- ACRO BIOTECH Inc. COVID-19 Antigen Test Cassette (FIA) (CE-IVD)
- ACRO BIOTECH Inc. COVID-19 Antigen Rapid Test (Oral Fluid) (CE-IVD)
- ACRO BIOTECH Inc. 2019-nCoV IgG/IgM Rapid Test (Brazil ANVISA - CE-IVD)
- Actim Oy Actim ELISA SARS CoV-2 IgG (CE-IVD)
- Adversis Pharma GmbH AProof SARS CoV-2 IgG ELISA (CE-IVD)
- Alfa Scientific Designs, Inc. Instant-view Plus Covid-19 Antibody Test (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)
- 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)
- AmonMed Biotechnology Co., Ltd COVID-19 IgM/IgG 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/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)
- AMS UK Ltd 2019-nCoV IgG/IgM Device (CE-IVD)
- AMS UK Ltd COVID-19 IgM ELISA (CE-IVD)
- AMS UK Ltd COVID-19 IgG ELISA (CE-IVD)
- AMS UK Ltd COVID-19 ELISA (total antibody) (CE-IVD)
- AMS UK Ltd COVID-19 Antigen ELISA (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 COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (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) Antigen Test Kit (Colloidal Gold) (CE-IVD)
- Anhui Deepblue Medical Technology Co., Ltd COVID-19 Antibody & Antigen Combo Test Kit (Colloidal Gold) (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)
- Apollo Biomedical LLC Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) (MHRA UK - CE-IVD)
- Applied Biological Materials Inc. GenomeCov19 IgM/IgG Rapid Test Kit (CE-IVD)
- ArcDia International Ltd mariPOC SARS-CoV-2 (CE-IVD)
- Artron Laboratories Inc. Artron COVID-19 Antigen Test Kit (CE-IVD)
- Assure Tech. (Hangzhou) Co., Ltd COVID-19 IgG/IgM Rapid Test Device (Brazil ANVISA - US FDA EUA - CE-IVD)
- Assure Tech. (Hangzhou) Co., Ltd COVID-19 Antigen Rapid Test Device (CE-IVD)
- Atlas Medical Atlas COVID-19 IgG/IgM Test Cassette (CE-IVD)
- Atlas Medical Atlas COVID-19 IgM Elisa Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 S1-RBD IgG Elisa Kit (CE-IVD)
- Atlas Medical Atlas COVID-19 Total Antibody Elisa Kit (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)
- Atlas-Link (Beijing) Technology Co. Ltd Covid-19 IgM/IgG Antibody Test (Colloidal Gold) (Australia TGA - CE-IVD)
- Augurix SA Simtomax CoronaCheck Antigen (CE-IVD)
- Augurix SA Simtomax Corona Check IgM/IgG Rapid COVID 19 test (CE-IVD)
- Autobio Diagnostics Co., Ltd Anti-SARS-CoV-2 (China NMPA EUA - US FDA EUA - Brazil ANVISA - 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 IgM Antibody Test Kit (ELISA) (CE-IVD)
- Beijing Abace Biology Co., Ltd COVID-19 IgG Antibody Test Kit (ELISA) (CE-IVD)
- Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) (CE-IVD)
- Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) (CE-IVD)
- Beijing Diagreat Biotechnologies Co., Ltd Time-Resolved Immunofluorescence Analyzer (CE-IVD)
- Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgG Antibody Determination Kit (CE-IVD)
- 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 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 (Up-converting Phosphor Technology) (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 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 Antigen Rapid Test Kit (Fluorescence) (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 IgM ELISA Test Kit (CE-IVD)
- Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (CE-IVD)
- Beijing Lepu Medical Technology Co., Ltd SARS-CoV-2 Antibody Test (colloidal gold immunochromatography) (Brazil ANVISA - CE-IVD)
- Beijing Lepu Medical Technology Co., Ltd 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) (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 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 Tigsun Diagnostics Co., Ltd Tigsun Flu A/B, RSV, COVID-19 Ag Combo 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 COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) (India CDSCO - 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 IgG Rapid Test (Semi-Quantitative) (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 Ag ELISA (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 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 IgG 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 SARS-CoV-2 IgM/IgG rapid assay kit (Colloidal Gold) (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)
- biocan diagnostics Inc. Tell Me Fast COVID19 Antigen Test (CE-IVD)
- biocan diagnostics Inc. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Ab Test (US FDA EUA - CE-IVD)
- 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)
- Biolidics Ltd 2019-nCoV IgG/IgM Antibody Detection Kit (Singapore HSA - CE-IVD)
- Biolidics Ltd ClearEpi™ SARS-CoV-2 Antigen Rapid Test (CE-IVD)
- bioLytical Laboratories Inc. INSTI COVID-19 Antibody Test (CE-IVD)
- BioMaxima S.A. COVID-19 Antigen Rapid Test (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)
- Bionote Inc. NowCheck COVID-19 IgM/IgG Test (Australia TGA - Korea export - CE-IVD)
- Bionote Inc. NowCheck COVID-19 Ag Test (Korea export - 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)
- BIOSYNEX SWISS SA BIOSYNEX COVID-19 Ag BSS (CE-IVD)
- BIOSYNEX SWISS SA BIOSYNEX COVID-19 BSS (Brazil ANVISA - Singapore HSA - CE-IVD)
- Biotical Health biotical SARS-CoV-2 Ag card test (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. AFIAS COVID-19, Viral Antigen (automated) (Philippines FDA - 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)
- Camtech Diagnostics Pte Ltd Camtech COVID-19 Rapid Test Kit (Singapore HSA - CE-IVD)
- 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)
- CerTest Biotec S.L. CerTest SARS-CoV-2 (CE-IVD)
- Changsha Sinocare Inc. SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method) (CE-IVD)
- Chil Tibbi Mal. San. Tic. Ltd Sti. Chil COVID-19 IgG/IgM (whole blood/serum/plasma) Rapid Test (CE-IVD)
- 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)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgM ELISA (CE-IVD)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgA ELISA (CE-IVD)
- Demeditec Diagnostics GmbH COVID-19 (SARS-CoV-2) IgG ELISA (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)
- DIA.PRO Diagnostic Bioprobes srl ACE2-RBD Neutralization Assay (CE-IVD)
- DIALAB GmbH DIAQUICK COVID-19 Ag Test (CE-IVD)
- 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)
- 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)
- 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 IgG Test Kit (Korea export - CE-IVD)
- DxGen Corp. Epithod® 616 COVID-19 IgM/IgG Test Kit (Korea export - CE-IVD)
- 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)
- Edinburgh Genetics Limited Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined (CE-IVD)
- Edinburgh Genetics Limited Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit (CE-IVD)
-
Epitope Diagnostics, Inc.
EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit (Singapore HSA - CE-IVD)
- Epitope Diagnostics, Inc. COVID-19 Nucleocapsid IgG Quantitative ELISA Kit (CE-IVD)
-
Epitope Diagnostics, Inc.
EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit (Singapore HSA - 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-NCP ELISA (IgG) (CE-IVD)
- EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA) (Australia TGA - Brazil ANVISA - Singapore HSA - CE-IVD)
- Eurospital S.p.A. SARS-COV-2 IgG (CE-IVD)
- 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)
- GenBody, Inc. GenBody COVID-19 Ag (CE-IVD)
- GenBody, Inc. GenBody COVID-19 IgM/IgG (Australia TGA - Brazil ANVISA - CE-IVD)
- Genelogic Research Limited Genelogic COVID-19 IgM/IgG Antibody Test Kit (Hong Kong MDACS - CE-IVD)
- General Biologicals Corporation GB SARS-CoV-2 Ab ELISA (CE-IVD)
- Genesprint Group Ltd Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARSCoV-2 (CE-IVD)
- Genesprint Group Ltd SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)
- Genitech NSAN Pharmaceutical Pvt. Ltd COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)
- Genobio Pharmaceutical Co., Ltd. COVID-19 Antigen Lateral Flow Assay (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 IgG Antibody Detection Kit (CLIA) (CE-IVD)
- Genobio Pharmaceutical Co., Ltd. COVID-19 IgM Lateral Flow Assay (CE-IVD)
- Genrui Biotech Inc. Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) (Brazil ANVISA - Singapore HSA - CE-IVD)
- Genrui Biotech Inc. SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (CE-IVD)
- Genrui Biotech Inc. SARS-CoV-2 and FluA+FluB Antigen Test Kit (CE-IVD)
- 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 IgM Rapid Test (REF: P2001) (CE-IVD)
- GenSure Biotech Inc. COVID-19/FluA/B Antigen Combo Rapid Test P2007 (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. GenSure™ COVID-19 IgG/IgM Rapid Test (REF: P2002) (CE-IVD)
- GenSure Biotech Inc. GenSure™ COVID-19 Antigen Rapid Kit (REF: P2004) (CE-IVD)
- Getein Biotech, Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody (Colloidal Gold) (India CDSCO - CE-IVD)
- 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 One COVID-19 IgM/IgG (CE-IVD)
- Green Cross Medical Science Corp. GENEDIA W COVID-19 Ag (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 Antibody Test (lateral flow method) (Singapore HSA - China NMPA EUA - Australia TGA - Brazil ANVISA - India CDSCO - CE-IVD)
- Hangzhou AllTest Biotech Co., Ltd COVID-19 Antigen Rapid Test (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 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 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 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 COVID-19 Antigen Rapid Test Cassette (Saliva) (CE-IVD)
- Hangzhou Clongene Biotech Co., Ltd COVID-19 Antigen Rapid Test Cassette (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 Influenza A+B Antigen Combo Rapid Test Cassette (CE-IVD)
- Hangzhou Deangel Biological Engineering Co., Ltd Novel Coronavirus S Glycoprotein Detection Kit (Brazil ANVISA - 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 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 Realy Tech Co., Ltd 2019-nCOV LgG/LgM Rapid Test Device (CE-IVD)
- Hangzhou Testsea Biotechnology Co., Ltd COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)
- Hecin Scientific, Inc. COVID-19 IgM Antibody Rapid Test Kit (China NMPA EUA - Brazil ANVISA - CE-IVD)
- Hoyotek Biomedical Co., Ltd Influenza A/B/Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) (CE-IVD)
- 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)
- 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)
- 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)
- Immunostep S.L. Anti-SARS-CoV-2 ELISA IgG (CE-IVD)
- Immunostep S.L. Anti-SARS-CoV-2 ELISA IgA (CE-IVD)
- IMMY clarus SARS-CoV-2 Total Antibody EIA (CE-IVD)
- Imunodiagnostika SARS-CoV-2 S IgG ELISA (CE-IVD)
- 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 IgG - ESR400G (CE-IVD)
- Institut Virion Serion GmbH SERION ELISA agile SARS-CoV-2 IgA - ESR400A (CE-IVD)
- InTec Products, Inc. Rapid SARS-CoV-2 Antibody (IgM/IgG) (CE-IVD)
- InTec Products, Inc. Rapid SARS-CoV-2 Antibody Test (CE-IVD)
- 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)
- 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 Superbio Biomedical Technology (Nanjing) Co., Ltd SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (US FDA EUA - CE-IVD)
- JinHuan Medical Instrument Co., Ltd (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (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 (Latex) (CE-IVD)
- Joinstar Biomedical Technology Co., Ltd COVID-19 Antigen Rapid Test (Colloidal Gold) (CE-IVD)
- Joinstar Biomedical Technology Co., Ltd SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold) (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 /MERS-CoV/ Influenza A&B Antigen 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)
- JOYSBIO (Tianjin) Biotechnology Co., Ltd COVID-19 Neutralizing Antibody Test Kit (Lateral Flow Rapid Test) (CE-IVD)
- KRISHGEN BioSystems Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test (CE-IVD)
- KRISHGEN BioSystems SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) ELISA (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 Biocard COVID-19 IgM/IgG Easy (CE-IVD)
- 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)
- 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)
- LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgM EIA Test (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™ COVID-19 ANTIGEN Test (Brazil ANVISA - Philippines FDA - CE-IVD)
- LumiraDx UK Ltd LumiraDx SARS-CoV-2 Ag Test (US FDA EUA - CE-IVD)
- MedicalSystem Biotechnology Co., Ltd COVID-19 IgM/IgG Rapid Test Cassette (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)
- Medisys International SA Gmate Covid-19 (CE-IVD)
- Medusa 19 Ltd Rapid Saliva Protein Test (CE-IVD)
- Medusa 19 Ltd Rapid Saliva Protein Test & Saturn Pass Mobile App (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)
- MicroDigital Co., Ltd MDGen AB96-COVID-19 IgG (CE-IVD)
- Mikrogen GmbH recomWell SARS-CoV-2 IgA (CE-IVD)
- Mikrogen GmbH recomWell SARS-CoV-2 IgG (CE-IVD)
- Mikrogen GmbH recomLine SARS-CoV-2 IgG (CE-IVD)
- Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay (CE-IVD)
- 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)
- 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 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) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) (CE-IVD)
- Nano-Ditech Corporation Fluoro-Check COVID-19 Antigen Test (CE-IVD)
- Nano-Ditech Corporation Nano-Check COVID-19 Antigen Test (CE-IVD)
- Nano-Ditech Corporation Nano-Check COVID-19 IgG Antibody Test (CE-IVD)
- Nano-Ditech Corporation Nano-Check COVID-19 IgG/IgM Antibody Test (CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 SP (Korea MFDS EUA - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 Ag (Korea export - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 Ag + Flu A&B (Korea export - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 IgG/IgM Duo (Korea MFDS EUA - CE-IVD)
- NanoEntek Inc. FREND™ COVID-19 total Ab (US FDA EUA - Korea export - CE-IVD)
- Nantong Egens Biotechnology Co., Ltd COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold) (Australia TGA - Brazil ANVISA - 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)
- NG Biotech NG-Test IgG-IgM COVID-19 (CE-IVD)
- NovaTec Immundiagnostica GmbH NovaLisa® COVID-19 (SARS-CoV-2) IgG (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)
- NTBio Diagnostics Inc. COVID-19 IgG/IgM Antibody Test Cassette (Australia TGA - CE-IVD)
- Operon SA Simple/Stick Ag SARS-CoV-2 (COVID-19) (CE-IVD)
- Ortho Clinical Diagnostics VITROS® Immunodiagnostic Products SARS-CoV-2 Antigen (CE-IVD)
- Pantest SA Pantest Coronavirus IgM/IgG (CE-IVD)
- Pantest SA Pantest Coronavirus Ag (INFARMED - CE-IVD)
- PCL Inc. PCL COVID19 IgG/IgM Rapid Gold (Korea MFDS EUA - Australia TGA - CE-IVD)
- PCL Inc. PCL COVID19 Ag Gold (CE-IVD)
- PCL Inc. PCL COVID19 Ag Rapid FIA (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)
- PharmAct AG SARS COVID-19 Rapid Test (CE-IVD)
- Pishtaz Teb Diagnostics SARS-CoV-2 IgM ELISA Kit (CE-IVD)
- Pishtaz Teb Diagnostics SARS-CoV-2 IgG ELISA Kit (CE-IVD)
- Precision Biosensor, Inc. Exdia COVID-19 IgG/IgM (CE-IVD)
- Precision Biosensor, Inc. PBCheck COVID-19 IgG/IgM (CE-IVD)
- Precision Biosensor, Inc. Exdia COVID-19 Ag (Korea export - CE-IVD)
- 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 IgM/IgG (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 IgM/IgG (CE-IVD)
- ProGnosis Biotech Rapid Test Ag 2019-nCoV (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)
- Prometheus Bio Inc. 2019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma) (CE-IVD)
- PROMOITALIA GROUP SPA DROP-TECH (CE-IVD)
- PROMOITALIA GROUP SPA SARS-CoV-2 Antibody Test (CE-IVD)
- ProteomeTech Inc. KOVIcheck COVID-19 IgG/IgM (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)
- 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)
- Quotient Suisse SA MosaiQ™ COVID-19 Antibody Microarray (US FDA EUA - CE-IVD)
- RapiGEN Inc. BIOCREDIT COVID-19 Ag (Brazil ANVISA - Philippines FDA - CE-IVD)
- RapiGEN Inc. BIOCREDIT COVID-19 IgG+IgM Duo (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)
- Resilient Supplier Resilient & Rápido Direct Read SARS-CoV-2 Antigen Influenza A/B Test (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)
- 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)
- 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)
- 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 DS-ЕIA-Anti-SARS-CoV-2-G Enzyme immunoassay for the detection of IgG - antibodies to SARS-CoV-2 (COVID-19) (CE-IVD)
- RPC Diagnostic Systems Anti-SARS-CoV-2 Enzyme immunoassay for the detection of antibodies to SARS-CoV-2 (COVID-19) (CE-IVD)
- Saladax Biomedical Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (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)
- SD BIOSENSOR, Inc. STANDARD Q COVID-19 IgM/IgG Duo Test (Brazil ANVISA - CE-IVD)
- SD BIOSENSOR, Inc. STANDARD F COVID-19 Ag FIA (Brazil ANVISA - CE-IVD)
-
SD BIOSENSOR, Inc.
STANDARD Q COVID-19 Ag Test (South Africa SAHPRA - Brazil ANVISA - CE-IVD - WHO EUL)
(validated ICMR)
- 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)
- 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)
- 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/Influenza A+B/RSV/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 COVID-19 and Influenza A+B Antigen Combo Rapid Test (Colloidal Gold) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd Covid-19 Antigen Rapid Test (Colloidal gold) (CE-IVD)
- Shanghai Chemtron Biotech Co. Ltd 2019-nCoV IgM Antibody Diagnostic Kit (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 Kehua Bio-engineering Co., Ltd Diagnostic kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) (CE-IVD)
- 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)
- Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Total Ab GICA Rapid Test (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 Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) (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 Lvshiyuan Biotechnology Co., Ltd Green Spring Flu A & Flu B & COVID-19 Ag Rapid Test (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 Lvshiyuan Biotechnology Co., Ltd Green Spring SARS-CoV-2 Antigen Rapid Test Kit (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 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 (Fluorescence 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 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 Render Bio-tech Co., Ltd. COVID-19 IgM & IgG Test (Immunochromatography) (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 GLINE-2019-nCoV Ag (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd GLINE-2019-nCoV IgM/IgG (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash 2019-nCoV NAb (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd Unicell-2019-nCoV Ag (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd iFlash-2019-nCoV Antigen (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd Unicell-2019-nCoV NAb (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 Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgM (CE-IVD)
- Shenzhen Yhlo Biotech Co. Ltd GLINE-2019-nCoV IgA (CE-IVD)
- Shenzhen Zhenrui Biotech Co., Ltd COVID-19 IgGg/IgM Rapid Test Cassette (WB/S/P) (CE-IVD)
- Sichuan Xincheng Biological Co., Ltd SARS-Cov-2 IgG/M Antibody Assay Kit by Immunofluorescence Chromatography Method (CE-IVD)
- Siemens Healthineers Atellica®IM SARS-CoV-2 Total (COV2T) (US FDA EUA - Health Canada - Australia TGA - Singapore HSA - CE-IVD)
- Siemens Healthineers CLINTEST Rapid COVID-19 Antigen Test (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 IgM (CLIA) (Brazil ANVISA - US FDA EUA - Singapore HSA - 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)
- Sona Nanotech Sona-COVID-19 LFA (CE-IVD)
- Spring Healthcare Services AG COVID-19 IgG/IgM Rapid Test (colloidal gold-based) (CE-IVD)
- Spring Healthcare Services AG SARS-Cov-2 Antigen Rapid Test Cassette (Swab) (US FDA EUA - Brazil ANVISA - CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgM (RDT) (CE-IVD)
- Sugentech, Inc. SGTi-flex COVID-19 IgM (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/IgG (manual) (CE-IVD)
- Sure Bio-Tech (USA) Co., Ltd SARS-CoV-2 IgM/IgG Ab Rapid Test (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 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)
- Syrona Limited COVID-19 IgG/IgM Rapid Test Cassette (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)
- 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)
- TestLine Clinical Diagnostics Ltd EIA COVID-19 NP IgA / EIA COVID-19 NP IgM / EIA COVID-19 NP IgG (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 SmartEIA COVID-19 NP IgA / SmartEIA COVID-19 NP IgG / SmartEIA COVID-19 NP IgM (CE-IVD)
- Tezted Oy SARSPLEX: Anti-SARS-CoV-2 IgM / IgG / IgA ELISA (measure individual Ig easily) (CE-IVD)
- 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 MNCHIP Technologies Co., Ltd. Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) (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)
- Tody Laboratories Int. Coronavirus (SARS-CoV-2) Antigen-Nasopharyngeal Specimen (CE-IVD)
- Tody Laboratories Int. Coronavirus (SARS-CoV-2) Antigen Oral Fluid (CE-IVD)
- Tridan/CBS Group ZEKMED COVID-19 IgG/IgM Rapid Test Device (Philippines FDA - SWISSMEDIC - CE-IVD)
- U2USystems (India) Pvt. Ltd 2019-ncoV IgG/IgM Test (CE-IVD)
- Veredus Laboratories Pte Ltd Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19 (Singapore HSA - 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 ELISA IgM+IgA (CE-IVD)
- Vircell S.L. COVID-19 VIRCLIA® IgM+IgA MONOTEST (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)
- 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)
- 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 UNscience Biotechnology Co., Ltd Covid-19 IgG/IgM Antibody Rapid Test Kit (Brazil ANVISA - 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 Antigen Rapid Test (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)
- 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)
- 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 IgM ELISA test (CE-IVD)
- Zhengzhou Humanwell Biocell Biotechnology Co., Ltd BIOCELL COVID-19 IgG ELISA test (CE-IVD)
- 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)
- Zybio Inc. SARS-CoV-2 IgM and IgG Antibody Assay Kit (CE-IVD)
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