| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 Ag Test | Device ID: 1263 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19 IgG/IgM Test | Device ID: 219 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19/Flu Ag Combo Test | Device ID: 1262 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Lituo Biotechnology Co. Ltd. | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 220 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hunan Yonghe-Sun Biotechnology Co. Ltd. | Commercial: SARS-COV-2 specific antibody test kit (Immunochromatography) | Device ID: 221 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: OJABIO SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method) | Device ID: 1575 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: OJABIO SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method) | Device ID: 3045 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method) | Device ID: 3018 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold Method) | Device ID: 3046 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-CoV Ag Saliva Rapid Test Card | Device ID: 2470 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-nCoV Ag Rapid Test Kit | Device ID: 2473 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zonka Biotech Co. Ltd. | Commercial: LollyTest 2019-nCoV IgG&IgM Antibody Rapid Test Kit | Device ID: 2474 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Huwel Lifesciences Pvt. Ltd. | Commercial: Quantiplus CORONA Virus (2019nCoV) detection kit | Device ID: 222 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: HymonBio Co. Ltd. | Commercial: Hymon Respiratory Triplex Panel Test Kit | Device ID: 3030 | Method: RT-PCR | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: HymonBio Co. Ltd. | Commercial: Hymon SARS-CoV-2 Test Kit | Device ID: 3002 | Method: RT-PCR | Target: | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Hyris Limited | Commercial: bKIT Virus Finder COVID-19 | Device ID: 2513 | Method: RT-PCR | Target: Nucleic acid | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ID.vet | Commercial: ID Screen SARS-CoV-2-N IgG Indirect ELISA Kit (manual, automated) | Device ID: 859 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ideal Tashkhis Atieh Co. | Commercial: SARS-CoV-2 IgG ELISA Kit | Device ID: 571 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ideal Tashkhis Atieh Co. | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 659 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: IEDAU INTERNATIONAL GMBH | Commercial: Covid-19 Antigen Schnelltest (Colloidales Gold) | Device ID: 2555 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Imegen | Commercial: Imegen SARS-CoV-2 | Device ID: 789 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Imegen | Commercial: Imegen SARS-CoV-2 plus | Device ID: 1115 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Immundiagnostik AG | Commercial: MutaPLEX® Coronavirus Real-Time-RT-PCR-Kit | Device ID: 2014 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Immundiagnostik AG | Commercial: PreventID ® SARS-CoV-2-Antigen | Device ID: 2815 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ImmunoDiagnostics Limited | Commercial: COVID-19 Ag Detection Kit (Colloidal Gold Immunochromatography) | Device ID: 2265 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Genespark SARS-CoV2 Quantitative detection of SARS-CoV2 genome | Device ID: 1905 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid New Coronavirus (COVID19) IgG/IgM Combo Test | Device ID: 1903 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid New Coronavirus (COVID19) Neutralizing Antibody Test | Device ID: 1904 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Immunospark s.r.l. | Commercial: Rapid SARS-Cov2 Antigen Test | Device ID: 1791 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Immy | Commercial: SARS-CoV-2 Total Antibody EIA | Device ID: 660 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: InActiv Blue | Commercial: InActiv Blue Saliva Collection Kit | Device ID: 2680 | Method: | Target: | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: InActiv Blue | Commercial: InActiv Blue Swab Collection Tube | Device ID: 2679 | Method: RT-PCR | Target: | Format: Other | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit | Device ID: 224 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: SCoV-2 Ag Detect Rapid Test | Device ID: 1421 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InBios International | Commercial: SCoV-2 Detect IgG ELISA | Device ID: 1409 | Method: ELISA | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: InBios International | Commercial: SCoV-2 Detect IgM ELISA | Device ID: 1410 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: InDevR Inc. | Commercial: COVID Serology Kit: Multiplexed Immunoassay | Device ID: 225 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Industrial Technology Research Institute Medical Device GMP Manufacturer | Commercial: iPMx Nucleic Acid Analyzer | Device ID: 3122 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ingenetix | Commercial: ViroReal Kit SARS-CoV-2 & SARS | Device ID: 788 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Innova Medical Group Inc. | Commercial: Innova SARS CoV-2 Antigen Rapid Qualitative Test | Device ID: 1801 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) | Device ID: 2285 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (Saliva) | Device ID: 2332 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Test Device | Device ID: 2287 | Method: | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2278 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2331 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co. Ltd. | Commercial: RAPID 2019-NCOV IGG/IGM COMBO TEST CARD | Device ID: 2286 | Method: | Target: Antibody, IgG, IgM | Format: 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