| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Attana AB | Commercial: Attana AVA SARS-CoV-2 IgG Immunoassay | Device ID: 2335 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Attomarker Ltd. | Commercial: Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP | Device ID: 44 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Aura Biotechnologies Ltd. | Commercial: Quick COVID-19 Colorimetric LAMP PCR | Device ID: 516 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Aura Biotechnologies Ltd. | Commercial: Quick COVID-19 Realtime Multiplex PCR | Device ID: 517 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Aurora Biomed Inc. | Commercial: SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation | Device ID: 45 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: AusDiagnostics | Commercial: SARS-CoV-2, Influenza and RSV 8-well | Device ID: 46 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Autobio Diagnostics Co. Ltd. | Commercial: Anti-SARS-CoV-2 Rapid Test | Device ID: 665 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Autobio Diagnostics Co. Ltd. | Commercial: SARS-CoV-2 IgG II CLIA Microparticles | Device ID: 919 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: Anti-SARS-CoV-2 RBD CLIA Microparticles | Device ID: 2429 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: Anti-SARS-CoV-2 RBD ELISA | Device ID: 2430 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2538 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test (self-test) | Device ID: 3082 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 NAb ELISA | Device ID: 2431 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Avacta Life Sciences Ltd. | Commercial: AffiDX SARS-CoV-2 Antigen Lateral Flow Test | Device ID: 2426 | Method: | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: AVALUN SAS | Commercial: Ksmart® SARS-COV2 Antigen Rapid Test | Device ID: 1800 | Method: Immunochromatography | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Avellino Lab | Commercial: Avellino SARS-CoV-2/COVID-19 (AvellinoCoV2) | Device ID: 48 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Avioq Bio-Tech Co. Ltd. | Commercial: Novel Coronavirus (2019-nCov)Antibody IgG/IgM Assay Kit (Colloidal Gold) | Device ID: 47 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Avioq Bio-Tech Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold) | Device ID: 1972 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AXIOM Gesellschaft für Diagnostica und Biochemica mbH | Commercial: COVID-19 Antigen Rapid Test Card | Device ID: 2101 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AXIOM Gesellschaft für Diagnostica und Biochemica mbH | Commercial: COVID-19 Antigen Saliva Test | Device ID: 2476 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Axium Bioresearch Inc. | Commercial: AxiumHealth COVID-19 IgG/IgM Antibody Test | Device ID: 775 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 1906 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: COVID-19 Antigen Saliva Test Kit | Device ID: 1911 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 1912 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: COVID-19 Neutralizing Antibody FIA | Device ID: 1910 | Method: Immunoassay | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: Dia Sure COVID-19 Antigen Rapid Test Device | Device ID: 2060 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: Dia Sure COVID-19 Antigen Rapid Test Device | Device ID: 2382 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ä°DÄ°L BÄ°OTECH ARAÅžTIRMA SAN. VE TÄ°C. Ltd. ÅžTÄ°. | Commercial: RevoDx SARS-CoV-2 qPCR Kit | Device ID: 2877 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: B-bio Co. Ltd. | Commercial: ChekR™ COVID-19 IgM/IgG Rapid test | Device ID: 1613 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: B-bio Co. Ltd. | Commercial: INNOGEN-B™ COVID-19 IgM/IgG Rapid test | Device ID: 1615 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BAG Diagnostics | Commercial: Viro-Q SARS-CoV-2 kit | Device ID: 703 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Baicare(Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2602 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Baicare(Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Real Time RT-PCR Kit | Device ID: 2738 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Baiya Phytopharm Co. Ltd. | Commercial: Baiya Rapid COVID-19 IgM/IgG test kit | Device ID: 50 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Bako Diagnostics | Commercial: BakoDx SARS-CoV-2 RNA test | Device ID: 704 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Bakter Medical s.r.o. | Commercial: Saligen | Device ID: 1782 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Bao Ruiyuan Biotech (Beijing) Co. Ltd. | Commercial: Novel Coronavivus(2019-nCov)Nucleic Acid Detection Kit-Multiple Fluorescence PCR | Device ID: 51 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BBB Inc. | Commercial: MARK-B COVID-19 Ag | Device ID: 2315 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BBB Inc. Obelis S.A.(BE) | Commercial: MARK-B COVID-19 Ag S | Device ID: 1234 | Method: Immunoassay | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG | Device ID: 2996 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG (1st IS) | Device ID: 2994 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgG II | Device ID: 2995 | Method: CLIA | Target: IgG | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Beckman Coulter | Commercial: ACCESS SARS-CoV-2 IgM | Device ID: 2997 | Method: CLIA | Target: IgM | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Kit For Rapid Detection of SARS-CoV-2 | Device ID: 2282 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD SARS-CoV-2 Reagents for BD MAX System | Device ID: 706 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD SARS-CoV-2/Flu for BD Max Systems | Device ID: 2883 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Veritor™ System for Rapid Detection of SARS CoV 2 | Device ID: 1065 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Becton Dickinson | Commercial: BioGX SARS-CoV-2 Reagents for BD MAX System | Device ID: 518 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Abace Biology Co. Ltd. | Commercial: COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1281 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Abace Biology Co. Ltd. | Commercial: COVID-19 Viral Antigen Test Kit (ELISA) | Device ID: 1282 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements