| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: ECOTEST COVID-19 Antigen Rapid Test Device | Device ID: 770 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device | Device ID: 1370 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 1584 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Test Kit | Device ID: 1578 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. | Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit | Device ID: 2280 | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. | Commercial: COVID-19 Antigen Nasal Test Kit | Device ID: 2277 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 2270 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. | Commercial: ECOTEST COVID-19 Antigen Rapid Test Device | Device ID: 2350 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd. | Commercial: Fastep COVID-19 Antigen Rapid Test Device | Device ID: 2364 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Assut Europe | Commercial: Covid-19 IgG/IgM RAPID TEST | Device ID: 1036 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ASSUT EUROPE SPA | Commercial: COVID-19 N.A.T. Neutralizing Antibodies Test | Device ID: 2195 | Method: Other | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ASSUT EUROPE SPA | Commercial: SARS-CoV-2 Antigen Rapid Swab | Device ID: 2248 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asterion Otel İnşaat Bilişim Medikal Maden Tic.Ltd.Şti. | Commercial: As-check | Device ID: 2454 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Astra Biotech GmbH | Commercial: SARS-CoV-2 Triplex PCR kit | Device ID: 1132 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atila BioSystems, Inc | Commercial: Atila iAMP COVID-19 SANO Assay | Device ID: 2184 | Method: LAMP | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atila BioSystems, Inc | Commercial: Atila iAMP COVID-2019 Detection Kit | Device ID: 43 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Ativa Medical | Commercial: Ativa Enhanced Screen | Device ID: 42 | Method: Other | Target: Other | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Link Technology Co., Ltd. | Commercial: NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Device ID: 2010 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical | Commercial: Atlas COVID-19 IgG/IgM Test Cassette | Device ID: 515 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical | Commercial: Atlas COVID-19 IgM Elisa Kit | Device ID: 773 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical | Commercial: Atlas COVID-19 Real Time RT-PCR Kit | Device ID: 774 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical | Commercial: Atlas COVID-19 S1-RBD IgG Elisa Kit | Device ID: 772 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical | Commercial: Atlas COVID-19 Total Antibody Elisa Kit | Device ID: 771 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| 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 NAb ELISA | Device ID: 2431 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS., LTD. | Commercial: SARS-CoV-2 NAb Q CLIA Microparticles | Device ID: 2232 | Method: CLIA | Target: Antibody | Format: Automated | 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 | Go to details |
| CE Marking: Yes | Manufacturer: AXIOM Gesellschaft für Diagnostica und Biochemica mbH | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2101 | 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: 2382 | 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: 2060 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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 |
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