| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Ab Rapid Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: Rapid Immunoassay Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID-19 Antigen Rapid Test Cassette | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID19 IgM/IgG Rapid Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | 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) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: | Go to details |
| CE Marking: No | Manufacturer: Suzhou Kangheshun Medical Technology | Commercial: SARS-CoV-2 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Swedicine AB | Commercial: Covid-19 Antigen Rapid Test Cassette | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Syrona Limited | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: T&D diagnostics Canada Pvt., Canada | Commercial: COVID-19 Antigen Rapid Test, Sienna | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: FORA COVID-19 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TaiDoc Technology Corp. | Commercial: VTRUST COVID-19 Antigen Rapid Test TD-4531 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tauschen Int. Ltd (Tauschen Groups) | Commercial: COVID - 19 RAPID TEST KIT / Antibody IgG & IgM Test Kit | 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 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc | Commercial: SARS-CoV-2 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: TD diagnostics | Commercial: 2019-nCoV IgG/IgM Rapid Test | 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 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Telepoint Medical Services LLC | Commercial: Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tersaco AG | Commercial: SARS CoV-2 IgG/IgM Rapid Test | 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 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgG | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 RBD IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 RBD IgG | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 RBD IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: Microblot-Array COVID-19 IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: Microblot-Array COVID-19 IgG | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: Microblot-Array COVID-19 IgM | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgG | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgG | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgM | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: testsealabs | Commercial: COVID-19 IgG/IgM Antibody Test(Colloidal Gold) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Tetracore Inc | Commercial: Multiplex detection and differentiation SARS-Cov-2 Serology Assay (manual) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tezted | Commercial: Oy SARSPLEX | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tezted | Commercial: SARSPLEX: Anti-SARS-CoV-2 IgM / IgG / IgA ELISA (measure individual Ig easily) | Method: ELISA | Target: Antibody, IgG, IgM, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: EliA SARS-CoV-2-Sp1 IgG test | Method: Immunoassay | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: OmniPATH COVID-19 Total Antibody ELISA Test | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin Era Biology Technology Co., Ltd | Commercial: COVID-19 IgM/IgG Lateral Flow Assay | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tianjin Jianbo Biological Co., Ltd | Commercial: SARS-CoV-2 Specific IgM and IgG Test Kit (Coillodal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin MNCHIP Technologies Co., Ltd | Commercial: Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tianjin New Bay Bioresearch C | Commercial: Quik Pac II COVID-19 IgG & IgM Test | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: COVDIAG SALIVA | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA CORONADIAG Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Ab IgG / IgM - Nucleocapsid (N protein) | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Antigen - Oral Fluid | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Antigen - Swab Specimen | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV-2) Neutralizing Antibodies | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Other | 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