| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: InTelos Inc. | Commercial: MAUVE COVID-19 Ag Test | Device ID: 1882 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: IDK® anti-SARS-CoV-2 IgG ELISA | Device ID: 1881 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: Ninonasal | Device ID: 1880 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Colloid Gold Immunoassay) | Device ID: 1879 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette(Oral Fluid) | Device ID: 1878 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 + Flu A&B Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab) | Device ID: 1877 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette(Nasal Swab) | Device ID: 1876 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | Commercial: COVID-19 NEUTRALISING Ab RAPID TEST | Device ID: 1875 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019- nCoV and Flu A/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay) | Device ID: 1874 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019- nCoV Antigen Rapid Test | Device ID: 1873 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold) | Device ID: 1872 | Method: Other | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | Device ID: 1871 | Method: Other | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Device ID: 1870 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit(Multiplex PCR Fluorescent Probe Method) | Device ID: 1869 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) | Device ID: 1868 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LINEAR CHEMICALS S.L.U. | Commercial: Cromatest COVID-19 Antigen Cassette | Device ID: 1867 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Coyote Bioscience Co. Ltd. | Commercial: DirectDetect SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) | Device ID: 1866 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Device ID: 1865 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | 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: Shanghai Liangrun Biomedicine Technology Co. Ltd. | Commercial: LionRun™️SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay) | Device ID: 1863 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: SARS-CoV-2 PLUS ELITe MGB® Kit | Device ID: 1862 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: SARS-CoV-2 ELITe MGB® Kit | Device ID: 1861 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescence Probe Method) | Device ID: 1859 | Method: Other | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: Nucleic Acid Extraction or Purification Kit (Manual method) | Device ID: 1858 | Method: N.A. | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: Nucleic Acid Extraction or Purification Kit | Device ID: 1857 | Method: Other | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Bioteke Taizhou Biotechnology Co. Ltd. | Commercial: Freeze-dried Novel Coronavirus (COVID-19) nucleic acid detection kit （Fluorescence PCR method） | Device ID: 1856 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GA Generic Assays GmbH | Commercial: GA CoV-2 Antigen Rapid Test | Device ID: 1855 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: Gmate® COVID-19 Ag Saliva | Device ID: 1854 | Method: Immunoassay | Target: Antigen | 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: ALLUM SRL | Commercial: DAILY TAMPON | Device ID: 1852 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®GENE Flu & SARS-CoV-2 | Device ID: 1851 | Method: RT-PCR | Target: Nucleic acid | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: MutaPLEX® CoV-2 MUT real time RT-PCR Kit | Device ID: 1850 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) | Device ID: 1849 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: SCREEN TEST COVID-19 SALIVA | Device ID: 1847 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®@QUICK SARS-CoV-2 Antigen | Device ID: 1846 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive) | Device ID: 1845 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Immuno Biotech Co. Ltd. | Commercial: Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive) | Device ID: 1844 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| 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: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: AndLucky SARS-CoV-2 Antigen Anterior Nasal Rapid Test (minimal invasive) | Device ID: 1842 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Anterior Nasal | Device ID: 1841 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 1840 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: SARS-COV-2 Ag & Influenza Combo Rapid Test | Device ID: 1839 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: Wuhan NanoDiagnosis for Health Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette (Colloidal Gold Method) | Device ID: 1837 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SACEM Hayat Teknolojileri A.S. | Commercial: iNADx Multiplex III COVID-19 RT-qPCR Kit | Device ID: 1836 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-PRESTO | Device ID: 1835 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COV-QUANTO | Device ID: 1834 | Method: ELISA | Target: Antigen | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-VIRO | Device ID: 1833 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: RapiGEN Inc. | Device ID: 1832 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Van Oostveen Medical B.V. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 1831 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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