| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: Rapid Immunoassay Test Cassette | Device ID: 466 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SARS-CoV-2 Rapid Antigen Test Cassette | Device ID: 2297 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID-19 Antigen Rapid Test Cassette | Device ID: 1275 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID19 IgM/IgG Rapid Test Cassette | Device ID: 749 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 Antigen Test Kit | Device ID: 1942 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: Surge Medical Inc. | Commercial: COVID-19 Neutralizing Antibody Test Kit | Device ID: 2762 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, 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: Suzhou Hybiome Biomedical Engineering Co. Ltd. | Commercial: SARS-CoV-2 IgG (Chemiluminescent Immunoassay) | Device ID: 2042 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co. Ltd. | Commercial: SARS-CoV-2 IgM (Chemiluminescent Immunoassay) | Device ID: 2043 | Method: CLIA | Target: Antibody, IgM | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Soochow University Saier Immuno Biotech Co. Ltd. | Commercial: InstantSure Covid-19 Ag CARD | Device ID: 3015 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou TianLong Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR Method) | Device ID: 2488 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Swedicine AB | Commercial: Covid-19 Antigen Rapid Test Cassette | Device ID: 1467 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Synbiotik Biotech | Commercial: VoliroN SARS-CoV-2 Real-Time PCR Kit | Device ID: 2966 | Method: RT-PCR | Target: | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Synbiotik Biotechnology | Commercial: Q-Check Rapid Lateral Flow Assay for SARS-CoV-2 Antigen Detection | Device ID: 2884 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Synbiotik Biotechnology | Commercial: SeroCap Anti-SARS-CoV-2 Neutralizing Kit | Device ID: 2901 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Syrona Limited | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 619 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Systaaq Diagnostic Prouducts | Commercial: 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit | Device ID: 395 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: TaiDoc Technology Corp. | Commercial: FORA COVID-19 Antigen Rapid Test | Device ID: 1192 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: FORA SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody) | Device ID: 2700 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: URIGHT SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody) | Device ID: 2701 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: VTRUST COVID-19 Antigen Rapid Test TD-4531 | Device ID: 1096 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: VTRUST SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody) | Device ID: 2702 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Taizhou ZECEN Biotech Co. Ltd. | Commercial: SARS-CoV-2 IgG/IGM Rapid t | Device ID: 2649 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TargetingOne Technology (Beijing) Corporation | Commercial: TARGETINGONE® SARS-CoV-2 Antigen Test | Device ID: 3066 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tauschen Int. Ltd. (Tauschen Groups) | Commercial: COVID - 19 RAPID TEST KIT / Antibody IgG & IgM Test Kit | Device ID: 620 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: INFO Covid-19 Ag Test | Device ID: 2584 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: INFO SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1753 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: RAPIDAN TESTER Covid-19 Ag Test | Device ID: 1751 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: RAPIDAN TESTER SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1752 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1690 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: TEST IT Covid-19 Ag Test | Device ID: 1689 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: TOYO Covid-19 Ag Test | Device ID: 1722 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: Toyo SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1723 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG Biotechnology Corp. | Commercial: ExProbe SARS-CoV-2 Testing Kit | Device ID: 1335 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG Biotechnology Corp. | Commercial: TBG SARS-CoV-2 IgG/IgM Rapid Test Kit | Device ID: 1336 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: Corona Virus Disease-19(COVID-19)IgG/IgM Rapid | Device ID: 1337 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 1339 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 1338 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 3093 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TECHNOGENETICS | Commercial: TGS COVID-19 IgG | Device ID: 2770 | Method: CLIA | Target: IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: TECHNOGENETICS | Commercial: TGS COVID-19 IgM | Device ID: 2771 | Method: CLIA | Target: IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: RAPID TEST SARS-CoV-2 IgM/IgG GOLD | Device ID: 1024 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: TGS Velox Ag COVID-19 POCT SALIVA (25 test) | Device ID: 2274 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tellgen Corporation | Commercial: SARS-CoV-2 Nucleic acid detection kit based on Cartridge Real-Time PCR platform | Device ID: 1979 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: TeraBioSafety Ltd. | Commercial: Coronavirus Breath Analyzer | Device ID: 1056 | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgA | Device ID: 1100 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgG | Device ID: 1101 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgM | Device ID: 1102 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, 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