| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: INGEZIM Covid 19 CROM | Device ID: 1682 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST | Device ID: 1681 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2 (ICA) | Device ID: 1680 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc | Commercial: Instant-view® PLUS COVID-19 Antigen Test | Device ID: 1678 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: COVID-19 IgG/IgM Rapid Test (For Reader) | Device ID: 1677 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: COVID-19 IgG/IgM Test Cassette (for Analyzer) | Device ID: 1676 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: ACON SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 1675 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing M&D Biotechnology Co. Ltd. | Commercial: 2019-nCoV Antigen Test Kit | Device ID: 1674 | Method: Immunoassay | Target: Antigen | Format: Lab-based | 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: ACON Laboratories, Inc | Commercial: Foresight SARS-CoV-2 IgM EIA Test Kit | Device ID: 1672 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Foresight SARS-CoV-2 IgG EIA Test Kit | Device ID: 1671 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Device ID: 1670 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: FIAflex SARS-CoV-2 Antigen FIA | Device ID: 1669 | Method: Immunoassay | Target: Antigen | Format: 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: Laipac Technology Inc. | Commercial: LooK SPOT | Device ID: 1667 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 Real-time RT-PCR Kit | Device ID: 1666 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: FluCov2 | Device ID: 1664 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: DyonMed SA | Commercial: CORONA-Ag | Device ID: 1662 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 IgG/M Antibody Assay kit by Colloidal Gold Method | Device ID: 1661 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method | Device ID: 1660 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 Antigen Assay kit by Immunofluorescence Chromatography method | Device ID: 1659 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit | Device ID: 1658 | Method: Immunoassay | Target: Antibody, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Immunostep S.L | Commercial: Anti-SARS-Cov-2 ELISA IgG | Device ID: 1657 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immunostep S.L | Commercial: Anti-SARS-Cov-2 ELISA IgA | Device ID: 1656 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal gold Immunoassay) | Device ID: 1655 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 Ag | Device ID: 1654 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovidAg | Device ID: 1651 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc | Commercial: SINGUWAY COVID-19 Ag Test | Device ID: 1650 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lansion Biotechnology Co., Ltd. | Commercial: (COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) | Device ID: 1649 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, Near POC / POC | 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: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Device ID: 1647 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: NG-Test SARS-CoV-2 Ag | Device ID: 1646 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2-(ICA) | Device ID: 1645 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: SARS-CoV-2 Antigen Test Cassette (Nasal Swab Specimen) | Device ID: 1644 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX System | Device ID: 1643 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit | Device ID: 1642 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: No | Manufacturer: ISIA | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Quantum Dots Immunofluorescence) | Device ID: 1640 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ISIA | Commercial: Novel Coronavirus (2019-nCoV) IgM/IgG Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1639 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eiken Chemical Co. Ltd | Commercial: Loopamp SARS-CoV-2 Detection kit | Device ID: 1638 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Hefei Biohit Healthcare | Commercial: SARS-CoV-2 IgM/IgG ANTIBODY TEST KIT | Device ID: 1637 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: H-Guard | Commercial: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold) | Device ID: 1636 | Method: Immunoassay | Target: Antibody | 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: 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: 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: 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: Tianjin New Bay Bioresearch C | Commercial: Quik Pac II COVID-19 IgG & IgM Test | Device ID: 1631 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: WHPM | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 1630 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: recomWell SARS-CoV-2 IgG | Device ID: 1629 | Method: Immunoassay | Target: Antibody, IgG, IgA | Format: Lab-based | 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