| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co. Ltd. | Commercial: 2019-nCOV IgM Antibody kit (ELISA) | Device ID: 845 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovid19 - SARS-CoV-2 IgM/IgG Antibody Rapid Test Device. | Device ID: 991 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | Device ID: 156 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined | Device ID: 662 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Epigentek Group Inc. | Commercial: SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit | Device ID: 1044 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Epitope Diagnostics Inc. | Commercial: EDI Novel Coronavirus COVID-19 IgG ELISA Kit | Device ID: 157 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Epitope Diagnostics Inc. | Commercial: EDI Novel Coronavirus COVID-19 IgM ELISA Kit | Device ID: 158 | Method: ELISA | Target: Antibody | 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 | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Eternal Materials Co. Ltd. | Commercial: COVIDual COVID-19 IgM/IgG Rapid Test | Device ID: 1066 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: INGEZIM Covid 19 CROM | Device ID: 1682 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: INGEZIM COVID 19 DR | Device ID: 1683 | Method: ELISA | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: NovaLisa SARS-CoV-2 IgG assay | Device ID: 725 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: VIROTECH SARS-CoV-2 IgG | Device ID: 880 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EUROFINS INGENASA | Commercial: INGEZIM COVID 19 SPIKE CROM | Device ID: 2458 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EUROFINS INGENASA | Commercial: INGEZIM COVID RBD-DR | Device ID: 2552 | Method: ELISA | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 ELISA (IgA) | Device ID: 160 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 ELISA (IgG) | Device ID: 883 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2 QuantiVac ELISA (IgG) | Device ID: 2743 | Method: ELISA | Target: Antibody | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: Anti-SARS-CoV-2-NCP ELISA (IgG) | Device ID: 849 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: EUROIMMUN AG | Commercial: SARS-CoV-2 NeutraLISA | Device ID: 2751 | Method: ELISA | Target: Antibody | Format: Automated, Fully automated (robot), Lab-based, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: fago medikal san. tic. Ltd. ÅŸti. | Commercial: FAMEX SARS-CoV-2 RAPID ANTIBODY TEST | Device ID: 2175 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit | Device ID: 2598 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Detection Kit | Device ID: 2730 | Method: | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Rapid | Device ID: 2726 | Method: | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Fosun SARS-CoV-2 Neutralization Antibody Rapid (Immunofluorescence) | Device ID: 2727 | Method: Immunoassay | Target: Antibody | Format: | 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 | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: GenaBio Diagnostics Inc. | Commercial: SARS-CoV-2 IgM/IgG (GICA) Test | Device ID: 1576 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenBody Inc. | Commercial: GenBody COVID-19 IgM/IgG | Device ID: 169 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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 | 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: Yes | Manufacturer: Genesprint Group Limited | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2 | Device ID: 1609 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genitech NSAN Pharmaceutical Pvt. Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 563 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) | Device ID: 786 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: GenScript Biotech Corporation | Commercial: cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit | Device ID: 2860 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 IgG/IgM Rapid Test (REF: P2002) | Device ID: 565 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 IgM Rapid Test (REF: P2001) | Device ID: 566 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Fluorescence) | Device ID: 1826 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Latex) | Device ID: 2112 | Method: Immunoassay | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for Novel Coronavirus(2019-nCoV) IgM/IgG antibody (Colloidal Gold) | Device ID: 190 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Fast Test Kit (Immunofluorescence Assay) | Device ID: 2592 | Method: Immunoassay | Target: Antibody | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Glallergen Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Neutralization Antibody Test Kit (Colloidal Gold Immunochromatography) | Device ID: 2707 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc. | Commercial: SARS-CoV-2 IgG/IgM Kit (manual) | Device ID: 192 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Green Cross Medical Science Corp. | Commercial: GENEDIA W ONE COVID 19 IgM&IgG | Device ID: 1145 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 1807 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (colloidal gold method) | Device ID: 1811 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Fluorescent immunochromatography) | Device ID: 1812 | Method: Immunochromatography | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: Coronavirus COVID-19 IgM/IgG Test Kit | Device ID: 1440 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: Coronavirus COVID-19 lgM/IgG Test Kit (colloidal) | Device ID: 1428 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co. Ltd. | Commercial: COVID-19 Neutralizing Antibody Test Kit | Device ID: 1668 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Finecare SARS-CoV-2 Antibody Test | Device ID: 206 | 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