| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV IgM/IgG | Device ID: 1082 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-2019-nCoV IgA | Device ID: 1081 | Method: Immunoassay | Target: Antibody | 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 | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-SARS-CoV-2 IgG-S | Device ID: 2697 | Method: | Target: Antibody | Format: | 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 | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: UNICELL-2019-nCoV NAb | Device ID: 1478 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co. Ltd. | Commercial: SARS-Cov-2 IgG/IgM Antibody Assay Kit by Immunofluorescence Chromatography Method | Device ID: 616 | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co. Ltd. | Commercial: SARS-Cov-2 IgG/M Antibody Assay kit by Colloidal Gold Method | Device ID: 1661 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: ADVIA Centaur CP SARS-CoV-2 IgG (sCOVG) | Device ID: 2022 | Method: Immunoassay | Target: Antibody | Format: Lab-based, Other | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Atellica IM SARS-CoV-2 IgG (sCOVG) | Device ID: 2023 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: SARS-CoV-2 Total (COV2T) assay | Device ID: 1049 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Silversite diagnostics.corp | Commercial: Antibody kit igg igm testing | Device ID: 1731 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc. | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 1155 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sinocare | Commercial: SARS-CoV-2 Antibody Test strip (colloidal Gold Method) | Device ID: 990 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SLSBio Co. Ltd. | Commercial: SSmarTest COVID19 Spike Protein Ab(IgM/IgG) Test | Device ID: 2631 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI 2019-nCoV IgG (CLIA) | Device ID: 374 | Method: Immunoassay | Target: Antibody | 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 | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) | Device ID: 1491 | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) | Device ID: 1299 | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check - COVID-19 IgG/IgM Test | Device ID: 1086 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spartacus-Biomed | Commercial: LFA COVID-19 IgG & IgM Rapid Test Device | Device ID: 2186 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 Antibody IgG-IgM Rapid Test Cassette | Device ID: 2616 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 Antibody Neutralizing Rapid Test Cassette | Device ID: 2615 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPRING HEALTHCARE SERVICES SP Z O O | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Device ID: 618 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech Inc. | Commercial: SGT anti-SARS-CoV-2 total Ab ELISA | Device ID: 1113 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech Inc. | Commercial: SGTi-flex COVID-19 IgM/IgG (RDT) | Device ID: 388 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: SARS-CoV-2 IgG Ab Rapid Test | Device ID: 392 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: SARS-CoV-2 IgM Ab Rapid Test | Device ID: 391 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Ab Rapid Test | Device ID: 390 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: Rapid Immunoassay Test Cassette | Device ID: 466 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID19 IgM/IgG Rapid Test Cassette | Device ID: 749 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method) | Device ID: 1932 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Surge Medical Inc. | Commercial: COVID-19 Neutralizing Antibody Test Kit | Device ID: 2762 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co. Ltd. | Commercial: SARS-CoV-2 IgG (Chemiluminescent Immunoassay) | Device ID: 2042 | Method: CLIA | Target: Antibody | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Hybiome Biomedical Engineering Co. Ltd. | Commercial: SARS-CoV-2 IgM (Chemiluminescent Immunoassay) | Device ID: 2043 | Method: CLIA | Target: Antibody | Format: Automated, Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Synbiotik Biotechnology | Commercial: SeroCap Anti-SARS-CoV-2 Neutralizing Kit | Device ID: 2901 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Syrona Limited | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 619 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: FORA SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody) | Device ID: 2700 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: URIGHT SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody) | Device ID: 2701 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: VTRUST SARS-CoV-2 Antibody Rapid Test (Neutralizing Antibody) | Device ID: 2702 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Taizhou ZECEN Biotech Co. Ltd. | Commercial: SARS-CoV-2 IgG/IGM Rapid t | Device ID: 2649 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tauschen Int. Ltd. (Tauschen Groups) | Commercial: COVID - 19 RAPID TEST KIT / Antibody IgG & IgM Test Kit | Device ID: 620 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1690 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Türklab Tibbi Mal. San. ve Tic. A.S. | Commercial: Toyo SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1723 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG Biotechnology Corp. | Commercial: TBG SARS-CoV-2 IgG/IgM Rapid Test Kit | Device ID: 1336 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: Corona Virus Disease-19(COVID-19)IgG/IgM Rapid | Device ID: 1337 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: RAPID TEST SARS-CoV-2 IgM/IgG GOLD | Device ID: 1024 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgA | Device ID: 1100 | Method: Immunoassay | Target: Antibody | 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