| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Creative Diagnostics | Commercial: ELISA: Anti-SARS-CoV-2 antibodies & NP antigen | Device ID: 908 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Bio-Techne | Commercial: Ella / Simple Plex COVID-19 16×4 Standard Panel | Device ID: 85 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgA | Device ID: 980 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgG | Device ID: 981 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIESSE Diagnostica Senese SPA | Commercial: ENZY-WELL SARS-CoV-2 IgM | Device ID: 982 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod SARS-CoV-2 qAg Test Kit | Device ID: 1717 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod® SARS-CoV-2 IgG Test Kit | Device ID: 1719 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod®616 COVID-19 Ag Test Kit | Device ID: 1718 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DxGen Corp. | Commercial: Epithod®616 IgG Test Kit | Device ID: 1720 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Erba Mannheim | Commercial: ErbaLisa COVID-19 IgG ELISA | Device ID: 533 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Erba Mannheim | Commercial: ErbaLisa COVID-19 IgM ELISA | Device ID: 534 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Foresight SARS-CoV-2 IgG EIA Test Kit | Device ID: 1671 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ACON Laboratories, Inc | Commercial: Foresight SARS-CoV-2 IgM EIA Test Kit | Device ID: 1672 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NanoEntek | Commercial: FREND COVID-19 IgG/IgM Duo | Device ID: 585 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: GA Generic Assays GmbH | Commercial: GA CoV-2 IgG/IgM/IgG+ | Device ID: 554 | Method: ELISA | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetic Analysis AS | Commercial: GA-map COVID-19 Fecal Test | Device ID: 1171 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: General Biologicals Corporation | Commercial: GB SARS-CoV-2 Ab ELISA | Device ID: 1586 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: GenBody, Inc | Commercial: GenBody FIA COVID-19 IgM/IgG | Device ID: 170 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: GeneFinder COVID-19 Plus RealAmp Kit | Device ID: 889 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genelogic Research Limited | Commercial: Genelogic COVID-19 IgM/IgG Antibody Test Kit | Device ID: 850 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP 2019-nCoV (SARS-CoV-2) Detection Kit | Device ID: 1222 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genmark Saglik Urunleri | Commercial: geneMAP Respiratory Viral PCR Panel 2 (2019-nCoV, Inf A/B, RSV A/B) | Device ID: 1221 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV NAb | Device ID: 1701 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Genetic PCR Solutions | Commercial: GPS 2019-nCoV qPCR kit | Device ID: 896 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: NovaTec Immundiagnostica GmbH | Commercial: GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG | Device ID: 2324 | Method: Immunoassay | Target: IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hayat Genetics Inc | Commercial: Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit | Device ID: 1230 | Method: LAMP | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Nucleocapsid Protein IgG ELISA (manual) | Device ID: 249 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) Spike Protein IgG ELISA (manual) | Device ID: 251 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgG ELISA Kit | Device ID: 1125 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Human anti-SARS-CoV-2 IgM ELISA | Device ID: 1124 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Quansys Biosciences | Commercial: Human COVID-19 (2-plex) | Device ID: 327 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human SARS-CoV-2 (Covid-19) Qualitative ELISA (manual) | Device ID: 253 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc | Commercial: ichroma COVID-19/Flu Ag Combo | Device ID: 1448 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | 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: No | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2 Double Antigen Multi-species | Device ID: 1727 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2-N IgG Indirect | Device ID: 1726 | Method: ELISA | Target: Antibody, IgG | Format: Automated, 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: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-2019-nCoV IgA | Device ID: 1081 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-2019-nCoV NAb | Device ID: 1477 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-SARS-CoV-2 IgG | Device ID: 1079 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: iFlash-SARS-CoV-2 IgM | Device ID: 1080 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Reagens Ltd. | Commercial: Inf-Cov2Quant™ Influenza A/B + SARS-CoV-2 Quantification Kit | Device ID: 2372 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgG antibody ELISA Test Kit | Device ID: 69 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 IgM antibody ELISA Test Kit | Device ID: 67 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 RT-PCR Test Kit | Device ID: 832 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 total antibody ELISA Test Kit | Device ID: 1111 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc | Commercial: Kewei COVID-19 total antibody rapid test | Device ID: 1112 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI 2019-nCoV IgG (CLIA) | Device ID: 374 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co., Ltd | Commercial: MAGLUMI 2019-nCoV IgM (CLIA) | Device ID: 375 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd. | Commercial: MAGLUMI SARS-CoV-2 Ag (CLIA) | Device ID: 2187 | Method: CLIA | Target: Antigen | 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