| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 1339 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 1338 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 3093 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: TD diagnostics | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1628 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TECHNOGENETICS | Commercial: TGS COVID-19 IgG | Device ID: 2770 | Method: CLIA | Target: IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: TECHNOGENETICS | Commercial: TGS COVID-19 IgM | Device ID: 2771 | Method: CLIA | Target: IgM | Format: Lab-based | 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, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics SRL | Commercial: TGS Velox Ag COVID-19 POCT SALIVA (25 test) | Device ID: 2274 | Method: Immunoassay | Target: Antigen | Format: Manual, 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 | Device ID: 399 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tellgen Corporation | Commercial: SARS-CoV-2 Nucleic acid detection kit based on Cartridge Real-Time PCR platform | Device ID: 1979 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: TeraBioSafety Ltd. | Commercial: Coronavirus Breath Analyzer | Device ID: 1056 | Method: Other | Target: Other | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tersaco AG | Commercial: SARS CoV-2 IgG/IgM Rapid Test | Device ID: 1030 | 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, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 NP IgG | Device ID: 1101 | 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 | Device ID: 1102 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: EIA COVID-19 RBD IgA | Device ID: 1136 | 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 | Device ID: 1137 | 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 | Device ID: 1138 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: Microblot-Array COVID-19 IgA | Device ID: 1106 | 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 | Device ID: 1107 | 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 | Device ID: 1108 | 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 | Device ID: 1103 | 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 | Device ID: 1104 | 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 NP IgM | Device ID: 1105 | 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 RBD IgA | Device ID: 1148 | 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 | Device ID: 1149 | 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 | Device ID: 1150 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Tetracore Inc. | Commercial: Multiplex detection and differentiation SARS-Cov-2 Serology Assay (manual) | Device ID: 401 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tezted | Commercial: Oy SARSPLEX | Device ID: 811 | 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) | Device ID: 874 | Method: ELISA | Target: Antibody, IgA, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Theragen Genome Care | Commercial: Theragen COVID-19 ASSAY | Device ID: 2165 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Therma Bright Inc. | Commercial: AcuVid COVID-19 Rapid Antigen Saliva Test | Device ID: 2110 | Method: Immunoassay | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: EliA SARS-CoV-2-Sp1 IgG test | Device ID: 1414 | 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 | Device ID: 1426 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Thermo Fisher Scientific | Commercial: TaqMan SARS-CoV-2 Assay Kit v2 | Device ID: 402 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath COVID-19 CE-IVD RT-PCR Kit | Device ID: 875 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath COVID-19 Combo Kit | Device ID: 403 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath™ COVID-19 Fast PCR Combo Kit 2.0 | Device ID: 2950 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath™ COVID-19 RNase P Combo Kit 2.0 | Device ID: 2949 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Thyrolytics AB | Commercial: Viraspec SARS-CoV-2 Antigen Rapid Test | Device ID: 2215 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin Era Biology Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Lateral Flow Assay | Device ID: 624 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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) | Device ID: 488 | 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) | Device ID: 404 | 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 | Device ID: 1631 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) E-gene | Device ID: 409 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) N-gene | Device ID: 408 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) RdRP-gene | Device ID: 410 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: SARS-CoV-2 E, RdRP or N gene CE-IVD 7 virus Respiratory Panel multiplex RT-PCR | Device ID: 406 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TNS Co. Ltd. (BioTNS) | Commercial: COVID-19 RT-PCR PNA KIT | Device ID: 1153 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA Autotest Nasal Covid-19 | Device ID: 2054 | Method: Immunochromatography | Target: Antigen | 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