| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: 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: Guangdong Wesail Biotech Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Test Kit | Device ID: 1668 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biopanda Reagents | Commercial: COVID-19 Rapid Antibody Test | Device ID: 1016 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: COVID-19 Rapid Antigen Test (Colloidal Gold) | Device ID: 1333 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401) | Device ID: 870 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd. | Commercial: COVID-19 RAPID IgG/IgM test kit | Device ID: 762 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Wondfo | Commercial: COVID-19 Rapid Test, WONDFO SARS-CoV-2 Antibody Test (Lateral Flow Method) | Device ID: 687 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: COVID-19 S-RBD IgG Antibody Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2327 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HGH Desinfections und Cosmetique GmbH | Commercial: Covid-19 Slide Test | Device ID: 1958 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: COVID-19 SPIKE QUANTITATIVE VIRCLIA® IgG MONOTEST | Device ID: 2081 | Method: Immunoassay | Target: Antibody, IgG | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: COVID-19 Test IgM/ IgG | Device ID: 983 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Camtech | Commercial: COVID-19 Viral Antigen Test Kit | Device ID: 1237 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: COVID-19 VIRCLIA IgG MONOTEST | Device ID: 422 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: COVID-19 VIRCLIA IgM+IgA MONOTEST | Device ID: 424 | Method: Immunoassay | Target: Antibody, IgA, IgM | Format: Automated, Manual | 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: Shenzhen AIVD Biotech Inc. | Commercial: COVID-19/ FluA/ FluB Antigen Combo Rapid Test Kit (Colloidal Gold Method) | Device ID: 3087 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: COVID-19/Flu A/B Antigen Combo Rapid Test | Device ID: 1454 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Device ID: 28 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19/Influenza A+ B Antigen Test Kit | Device ID: 1943 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co. Ltd. | Commercial: COVID-19/Influenza A+B Antigen Combo Rapid Test | Device ID: 1365 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19/Influenza A/Influenza B Detection Kit | Device ID: 2330 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co. Ltd. | Commercial: COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold) | Device ID: 933 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Pharmatech | Commercial: COVID19 IgG/IgM Rapid Test | Device ID: 686 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Novus Biologicals | Commercial: COVID19 IgG/IgM Rapid Test Kit | Device ID: 685 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: D-tek s.a. | Commercial: COVID5GDIV-24 | Device ID: 1673 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: CovidAg | Device ID: 1663 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: COVIDTECH One Step SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 1452 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eternal Materials Co. Ltd. | Commercial: COVIDual COVID-19 IgM/IgG Rapid Test | Device ID: 1066 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: CoviDx | Device ID: 350 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Group | Commercial: COVISCREEN test for detection of IgM/IgG/IgA antibodies | Device ID: 815 | Method: Immunoassay | Target: Antibody, IgA, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test | Device ID: 2343 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CRT (COVID 19 RAPID TEST) | Device ID: 1163 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: CVAG4080A – GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP Swab) | Device ID: 2319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dablood pharmaceutical | Commercial: DABLOOD COVID-19 IgM/IgG Rapid Antibody Test | Device ID: 1634 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ALLUM SRL | Commercial: DAILY TAMPON | Device ID: 1852 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: DART Diagnostics | Commercial: DART COVID-19 | Device ID: 145 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dejavu Medikal San. Tic.Ldt.Åžti | Commercial: Dejavu COVİD-19 Antigen Rapit test (nazofaringeal/ orafaringel swap) | Device ID: 2453 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2 | Device ID: 1609 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Novatech | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 | Device ID: 1582 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co. Ltd. | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 | Device ID: 440 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) | Device ID: 2167 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold) | Device ID: 2178 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Lionrun | Commercial: Diagnostic kit for antibody IgM/IgG of Novel Coronavirus COVID-19 | Device ID: 1633 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) | Device ID: 879 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 1274 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: DIAQUICK COVID-19 Ag Cassette | Device ID: 1375 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: Diaquick Covid-19 IgG/IgM | Device ID: 1055 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: DIAQUICK COVID-19 IgG/IgM Cassette Rapid Test | Device ID: 986 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: Diasia | Device ID: 1977 | Method: Immunoassay | Target: Antigen | Format: | 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