| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: NAISSA SARS-COV-2 IgG | Device ID: 1087 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: NAISSA SARS-COV-2 IgM | Device ID: 1133 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Neomedica d.o.o. | Commercial: NAISSA SARS-COV-2 S1/S2/RBD Neutralizing antibodies | Device ID: 2377 | Method: ELISA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Antibody Detection Kit | Device ID: 2306 | Method: Immunoassay | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Detection Kit | Device ID: 2305 | Method: Immunoassay | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Newbury Pharmaceuticals S.A | Commercial: COVID-19 Coronavirus Rapid Test Kit | Device ID: 1029 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NG Biotech | Commercial: NG-Test IgG-IgM COVID-19 | Device ID: 865 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa COVID-19 (SARS-CoV-2) IgA | Device ID: 587 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa COVID-19 (SARS-CoV-2) IgG | Device ID: 588 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa COVID-19 (SARS-CoV-2) IgM | Device ID: 589 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: NovaLisa SARS-CoV-2 (COVID-19) | Device ID: 819 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Novatech | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 | Device ID: 1582 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Novatech | Commercial: NOVACHECK Diagnostic kit (collodial gold) for IgG/IgM Antibody to SARS-CoV-2 | Device ID: 1393 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NTBio Diagnostics Inc. | Commercial: COVID-19 IgG/IgM Antibody Test Cassette | Device ID: 661 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CRT (COVID 19 RAPID TEST) | Device ID: 1163 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OPERON S.A. | Commercial: SIMPLE IgA/IgM/IgG SARS-CoV-2 | Device ID: 2171 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: OPTI Medical Systems | Commercial: OPTI SARS-CoV-2 Total Antibody Test Kit | Device ID: 1422 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ortho Clinical Diagnostics | Commercial: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG | Device ID: 795 | Method: CLIA | Target: Antibody | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ortho Clinical Diagnostics | Commercial: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total | Device ID: 590 | Method: CLIA | Target: Antibody | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: GeneFinder™ COVID-19 IgG/IgM Rapid Test | Device ID: 3102 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method | Device ID: 474 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Gold - OZO SARS-CoV-2 IgG Method | Device ID: 475 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Silver - OZO SARS-CoV-2 IgM Method | Device ID: 476 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest de Coronavirus IgM/IgG 2019-n-CoV | Device ID: 1003 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 IgG/IgM Rapid Gold | Device ID: 307 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antibody Detection Kit (Colloidal Gold Immunochromatographic assay) | Device ID: 310 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-CoV-2 Rapid TesIgM/IgG | Device ID: 485 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-COV-2 Rapid Test | Device ID: 501 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: Gmate COVID-19 Neutralizing antibody | Device ID: 2861 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID-19 Ag Neutralizing Antibody | Device ID: 2916 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: SARS-CoV-2 IgG ELISA | Device ID: 596 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pishtaz Teb Diagnostics | Commercial: SARS-CoV-2 IgM ELISA Kit | Device ID: 597 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Plexense Inc. | Commercial: ACCEL ELISA COVID-19 kit | Device ID: 2005 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1070 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2227 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | Commercial: PRIMA COVID-19 IgG/IgM Rapid Test (For Professional Use) | Device ID: 318 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Antibody Rapid Detection Kit（Colloidal Gold） | Device ID: 2486 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal Gold） | Device ID: 2485 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Proel Biotech Ltd. | Commercial: SARS-CoV-2 IgG antibody detection kit (ELISA) | Device ID: 1482 | Method: ELISA | Target: Antibody | Format: Automated, Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCoV IgG | Device ID: 1499 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCov IgM | Device ID: 1500 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Bio-Shield 2019-nCov Total Ig | Device ID: 1498 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Rapid test 2019-nCoV Total Ig | Device ID: 1496 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prometheus Bio Inc. | Commercial: 2019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma) | Device ID: 868 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: COVIDTECH One Step SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 1452 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 463 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-COV-2 IGM/IGG ANTIBODY RAPID TEST | Device ID: 1340 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Quotient Limited SA | Commercial: MosaiQ COVID-19 Antibody Microarray | Device ID: 600 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 IgG+IgM Duo | Device ID: 336 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 IgG/IgM Combo | Device ID: 1716 | Method: Immunoassay | Target: Antibody | 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