| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Saliva Test Kit | Device ID: 1579 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 664 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody FIA | Device ID: 1577 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19& Influenza A/B& RSV Antigen Combo Rapid Test | Device ID: 5824 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: ECOTEST COVID-19 Antigen Rapid Test Device (Nasal swab, Nasopharyngeal swab, Oropharyngeal swab) | 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: ECOTEST COVID-19 Antigen Rapid Test Device (Nasopharyngeal swab, Oropharyngeal swab) | 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: ECOTEST COVID-19 Antigen Rapid Test Device | Device ID: 4075 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: FaStep COVID-19 Antigen Nasal Test Kit | Device ID: 2469 | Method: Immunochromatography | Target: Antigen | Format: 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: 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 Antigen Rapid Tests for Self-Testing | Device ID: 2932 | Method: Immunoassay | Target: Antigen | Format: Manual, 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: 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 Ä°nÅŸaat BiliÅŸim Medikal Maden Tic. Ltd. Åžti. | Commercial: As-check | Device ID: 2454 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Link Technology Co. Ltd. | Commercial: FASPIT™ SARS-CoV-2 Antigen Saliva Test Kit | Device ID: 2937 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Link Technology Co. Ltd. | Commercial: NOVA Test® SARS-CoV-2 Antigen Home Test Kit | Device ID: 2956 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | 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 GmbH | Commercial: Atlas COVID-19 Antigen (Nasal Swab) Test Cassette | Device ID: 2959 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Atlas Medical GmbH | 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 GmbH | 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 GmbH | 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 GmbH | 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: 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: 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: 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 |
| 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: 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 |
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