CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Core Technology Co. Ltd. | Commercial: COVID-19 IgM/IgG Ab Test | Device ID: 132 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Core Technology Co. Ltd. | Commercial: COVID-19 Saliva Ag Test | Device ID: 1915 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CORETEST, INC. | Commercial: COVID-19 Ag Test | Device ID: 2967 | Method: | Target: | Format: | Go to details |
CE Marking: Yes | Manufacturer: Coris BioConcept | Commercial: Covid-19 Ag K-SeT | Device ID: 2648 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Coris BioConcept | Commercial: COVID-19 Ag Respi-Strip | Device ID: 133 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Coris BioConcept | Commercial: COVID-19 Sero NP/RBD | Device ID: 2002 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CORMAY | Commercial: CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT | Device ID: 1810 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CORMAY | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Device ID: 1074 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Coyote Bioscience Co. Ltd. | Commercial: 2019-nCoV Prep Free QPCR Assay | Device ID: 134 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Coyote Bioscience Co. Ltd. | Commercial: DirectDetect SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe) | Device ID: 1866 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Credo Diagnostics Biomedical | Commercial: VitaPCR COVID-19 assay | Device ID: 141 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: Aria COVID-19 Ag Rapid Test | Device ID: 1853 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: Aridia COVID-19 Real Time PCR Test | Device ID: 143 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 Ag Rapid Test | Device ID: 1581 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 IgG/IgM Rapid Test | Device ID: 902 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: cue health Inc. | Commercial: cue health | Device ID: 2655 | Method: Digital-PCR | Target: | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Cypress Diagnostics | Commercial: COVID-19 Ag Rapid Test | Device ID: 2499 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: D-tek s.a. | Commercial: COVID5GDIV-24 | Device ID: 1673 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DAAN Gene Co. Ltd. of Sun Yat-sen University | Commercial: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit | Device ID: 144 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Dablood pharmaceutical | Commercial: DABLOOD COVID-19 IgM/IgG Rapid Antibody Test | Device ID: 1634 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Kit Multiplex (q)RT-PCR(X) for detection of SARS-CoV-2 | Device ID: 2657 | Method: RT-PCR | Target: | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen | Device ID: 1305 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Combo Covid-19/Influenza A+B Antigen (tampon nazofaringian)) | Device ID: 1226 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Covid-19 Antigen (tampon nazal) | Device ID: 2986 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid Covid-19 Antigen (tampon nazofaringian) | Device ID: 1225 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: DDS DIAGNOSTIC SRL | Commercial: Test Rapid IgG/IgM 2019-nCoV | Device ID: 1073 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dejavu Medikal San. Tic.Ldt.Åžti | Commercial: Dejavu COVİD-19 Antigen Rapit test (nazofaringeal/ orafaringel swap) | Device ID: 2453 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: One check 2019-nCoV IgG/IgM | Device ID: 1007 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 Ag | Device ID: 2088 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 Ag Saliva | Device ID: 2637 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 IgG Spike RBD | Device ID: 2638 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Demeditec Diagnostics GmbH | Commercial: COVID-19 (SARS-CoV-2) IgA ELISA | Device ID: 840 | Method: ELISA | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Demeditec Diagnostics GmbH | Commercial: COVID-19 (SARS-CoV-2) IgG ELISA | Device ID: 841 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Demeditec Diagnostics GmbH | Commercial: COVID-19 (SARS-CoV-2) IgM ELISA | Device ID: 842 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Devidia GmbH | Commercial: Dediatest 2019-nCoV Antigen Rapid Test | Device ID: 2190 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Devidia GmbH | Commercial: Dediatest 2019-nCoV Antigen Rapid Test (Nasopharyngeal) | Device ID: 2574 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Devidia GmbH | Commercial: Dediatest Frontnasal 2019-nCoV Antigen | Device ID: 2575 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Devidia GmbH | Commercial: Dediatest Frontnasal SARS-CoV Antigen Schnelltest | Device ID: 2192 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Devidia GmbH | Commercial: Dediatest IgG-Spike | Device ID: 2193 | Method: Immunochromatography | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dewei Medical Equipment Co. Ltd. | Commercial: Covid-19 (2019-nCoV) Antigen Rapid Test Cassette | Device ID: 2279 | Method: Immunochromatography | Target: Antibody, Antigen, IgG | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dia Sure Immunodiagnostic LLP | Commercial: DSI COVID-19 Ag RAPID TEST | Device ID: 3144 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: ACE2-RBD Neutralization Assay | Device ID: 2462 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 IgA | Device ID: 2455 | Method: ELISA | Target: IgA | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 IgG | Device ID: 537 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 IgG Confirmation | Device ID: 539 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 IgG/IgM Confirmation and Typing | Device ID: 2461 | Method: ELISA | Target: IgG, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 IgM | Device ID: 538 | Method: ELISA | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 RNA Vs 2 | Device ID: 2460 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: COVID-19 Spike 1&2 IgG | Device ID: 2456 | Method: ELISA | Target: IgG | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 ACE2-RBD NEUTRALIZATION | Device ID: 2479 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | 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