| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: 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: 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: 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: 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: 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 |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: Toda Coronadiag + | Device ID: 1959 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA CORONADIAG Ag | Device ID: 1466 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TODA PHARMA | Commercial: TODA Covdiag Saliva | Device ID: 1913 | Method: Immunochromatography | 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) | Device ID: 1936 | 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 | Device ID: 1934 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Antigen - Swab Specimen | Device ID: 1935 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV-2) Neutralizing Antibodies | Device ID: 1933 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Other | Go to details |
| CE Marking: Yes | Manufacturer: TP Medicare GmbH | Commercial: Trueline COVID-19 Ag Rapid Test | Device ID: 1497 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TransGen Biotech Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR ) | Device ID: 1750 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tregena | Commercial: 3gamma COVID-19 IgA / IgM / IgG | Device ID: 1026 | Method: Immunoassay | Target: Antibody, IgA, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Trinity Biotech plc | Commercial: Uni-Gold SARS_CoV-2 Antigen Test | Device ID: 3152 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences (China) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 1465 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences (China) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2074 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences (China) Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Rapid Test Kit (Colloidal Gold) | Device ID: 1461 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: Biocard Covid-19 Rapid Test | Device ID: 1116 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: COVID KAVACH Anti-SARS CoV-2 Human IgG ELISA | Device ID: 1117 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: COVIDscreen Plus ELISA Kit | Device ID: 1118 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: COVIDsure Multiplex Realtime RT-PCR Kit | Device ID: 625 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: COVIDsure Pro Multiplex RT PCR Kit | Device ID: 1119 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: RNAsure - Covid-19 RNA Extraction Kit | Device ID: 1120 | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: RNAsure RNA Extraction Kit | Device ID: 951 | Method: Other | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: ViSure transport kit | Device ID: 816 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: U2USystems (India) Pvt. Ltd. | Commercial: 2019-ncoV IgG/IgM Test | Device ID: 489 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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