| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive) | Device ID: 1843 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin MNCHIP Technologies Co., Ltd | Commercial: Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) | Device ID: 404 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: H&Z Life Science Co. Ltd | Commercial: Anti-COVID-19 virus IgM/IgG Test Kit (lateral flow assay) | Device ID: 1172 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 ELISA (IgA) | Device ID: 160 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 ELISA (IgG) | Device ID: 883 | 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: 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: Biocheck GmbH | Commercial: Anti-SARS-CoV-2 IgG | Device ID: 1099 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mediagnost | Commercial: Anti-SARS-CoV-2 IgG ELISA | Device ID: 1625 | Method: ELISA | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co., Ltd | Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit | Device ID: 1864 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co., Ltd. | Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit | Device ID: 2046 | Method: Immunochromatography | Target: Antibody | 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., 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: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2-NCP ELISA (IgG) | Device ID: 849 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Silversite diagnostics.corp | Commercial: Antibody kit igg igm testing | Device ID: 1731 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lifotronic Technology Co, Ltd | Commercial: Antigen Rapid Test Ag SARS-CoV-2 | Device ID: 1592 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: A. Menarini Diagnostics | Commercial: ANTIGEN RAPID TEST CASSETTE SARS-COV-2 (SWAB) | Device ID: 1608 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co., Ltd | Commercial: Antigen Rapid Test COVID-19 Coretests | Device ID: 1594 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hologic | Commercial: Aptima SARS-CoV-2 Assay (Panther System) | Device ID: 972 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: AQ-TOP COVID-9 Rapid Detection Kit | Device ID: 944 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech, Inc | Commercial: Aria COVID-19 Ag Rapid Test | Device ID: 1853 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech, Inc | Commercial: Aridia COVID-19 Real Time PCR Test | Device ID: 143 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Luminex Corp. | Commercial: ARIES SARS-CoV-2 Assay | Device ID: 481 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ARISTA Biotech Pte. Ltd | Commercial: ARISTA COVID-19 Antigen Rapid Test | Device ID: 1926 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Artron Laboratories Inc | Commercial: Artron COVID-19 Antigen Test | Device ID: 1618 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Artron Laboratories Inc | Commercial: Artron COVID-19 IgM/IgG Antibody Test | Device ID: 1729 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual, Near POC / POC | 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: 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: Asan Pharmaceutical Co., Ltd. | Commercial: Asan Easy Test COVID-19 Ag | Device ID: 2251 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 IgG/IgM | Device ID: 1760 | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test Flu/COVID-19 Ag Combo | Device ID: 1761 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Microgenics Corporation | Commercial: ASAPath COVID-19 Antigen Rapid Test | Device ID: 2179 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: asdf | Commercial: asdf | Device ID: 2360 | Method: Digital-PCR | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: ASSURE SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 937 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Atellica IM SARS-CoV-2 Antigen (CoV2Ag) | Device ID: 2015 | Method: Immunoassay | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Atellica IM SARS-CoV-2 IgG (sCOVG) | Device ID: 2023 | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | 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: 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: Yes | Manufacturer: Macrogen | Commercial: AxenTM COVID-19 Ag RAPID | Device ID: 2125 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Macrogen | Commercial: AxenTM COVID-19 IgM/IgG RAPID | Device ID: 2126 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Omixon Biocomputing Kft. | Commercial: AzureSeq CE qPCR Kit SARS-CoV-2 for 200 Reactions | Device ID: 2363 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BBB Inc. | Commercial: BBB Inc. | Device ID: 2315 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Kit For Rapid Detection of SARS-CoV-2 | Device ID: 2282 | Method: Immunoassay | Target: Antigen | Format: Manual | 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