CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Guangzhou Biokey Health Technologies Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit(Colloidal Gold) | Device ID: 3021 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Rapid Test(Nasopharyngeal Swab) | Device ID: 2387 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: T&D diagnostics Canada Pvt. Canada | Commercial: COVID-19 Antigen Rapid Test, Sienna | Device ID: 1598 | 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: Yes | Manufacturer: Ulti Med Products GmbH | Commercial: COVID-19 Antigen Saliva Test (Immunochromatography) | Device ID: 1641 | 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: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Saliva Test Kit | Device ID: 2037 | 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 Saliva Test Kit | Device ID: 1579 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: IEDAU INTERNATIONAL GMBH | Commercial: Covid-19 Antigen Schnelltest (Colloidales Gold) | Device ID: 2555 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Blue Cross Bio-Medical(Beijing) Co. Ltd. | Commercial: COVID-19 Antigen Test | Device ID: 2627 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Redcell Biyoteknoloji | Commercial: COVID-19 Antigen Test | Device ID: 1715 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: RDSM nv | Commercial: COVID-19 Antigen test | Device ID: 1238 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Ulti Med Products GmbH | Commercial: COVID-19 Antigen test | Device ID: 1378 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Ulti Med Products GmbH | Commercial: COVID-19 Antigen Test (Nasopharyngeal Swab) | Device ID: 1455 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Cassette | Device ID: 1392 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Dian Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Cassette | Device ID: 2629 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab)(FIA) | Device ID: 2388 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Test cassette (FIA) | Device ID: 1254 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 Antigen Test Cassette (For Analyzer) | Device ID: 1700 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Test Cassette (Nasopharyngeal Swab) | Device ID: 2302 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Test for Self Testing | Device ID: 1476 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Linkcare Health Services (Diagnos BT) | Commercial: Covid-19 Antigen Test Kit (Colloidal Gold) | Device ID: 1353 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) | Device ID: 2869 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Color Latex Immunoassay) for self-testing use | Device ID: 3123 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) | Device ID: 1648 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (DryColorLatex Immunoassay) | Device ID: 2818 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Xiamen AmonMed Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography) | Device ID: 1279 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen/Flu A+B Antigen Combo Rapid Test Cassette | Device ID: 1756 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen/FLU A+B Antigen Combo Rapid Test Cassette (Colloidal Gold Method) | Device ID: 1838 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Newbury Pharmaceuticals S.A | Commercial: COVID-19 Coronavirus Rapid Test Kit | Device ID: 1029 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Anbang (Xiamen) Biotechnology Co. Ltd. | Commercial: COVID-19 Hybrid Capture Fluorescence Immunoassay Test | Device ID: 32 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: COVID-19 IgG Antibody Test Kit (colloidal gold method) | Device ID: 1806 | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: COVID-19 IgG IgM Test | Device ID: 1298 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG Rapid Test | Device ID: 1395 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 IgG Rapid Test | Device ID: 1695 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG Rapid Test (cassette) | Device ID: 1383 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 IgG Rapid Test (strip) | Device ID: 1384 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acro Biotech Inc. | Commercial: COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2427 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2441 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 IgG Rapid Test Cassette(Whole blood/Serum/Plasma) | Device ID: 5744 | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Invenio Medical | Commercial: COVID-19 IgG/IgM Ab Rapid Test | Device ID: 1635 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Biogate Laboratories Ltd. | Commercial: COVID-19 IgG/IgM Ab Rapid Test | Device ID: 776 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method) | Device ID: 1932 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co. Ltd. | Commercial: Covid-19 IgG/IgM Antibody Rapid Test Kit | Device ID: 634 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Verify Diagnostics Inc. | Commercial: Covid-19 IgG/IgM Antibody Test | Device ID: 628 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: NTBio Diagnostics Inc. | Commercial: COVID-19 IgG/IgM Antibody Test Cassette | Device ID: 661 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Testsea Biotechnology Co. Ltd. | Commercial: COVID-19 IgG/IgM Antibody Test(Colloidal Gold) | Device ID: 1632 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 IgG/IgM Combined Test kit(Colloidal Gold Method) | Device ID: 995 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Liming Bio-Products Co. Ltd. | Commercial: COVID-19 IgG/IgM Combo Rapid Test Device | Device ID: 264 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hunan Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 220 | 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