| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovation Biotechnology Co. Ltd. | Commercial: COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method) | Device ID: 2055 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: GenScript Biotech Corporation | Commercial: cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit | Device ID: 2860 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: LINEAR CHEMICALS S.L.U. | Commercial: Cromatest COVID-19 Antigen Cassette | Device ID: 1867 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Oncosem Onkolojik Sistemler San. ve Tic. A.S. | Commercial: CRT (COVID 19 RAPID TEST) | Device ID: 1163 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: Hangzhou AllTest Biotech Co. Ltd. | Commercial: CVAG4080A – GSD NovaGen SARS-CoV-2 Ag Rapid Test (NP Swab) | Device ID: 2319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: ALLUM SRL | Commercial: DAILY TAMPON | Device ID: 1852 | Method: Immunoassay | Target: Antigen | Format: 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: Nal von minden GmbH | Commercial: dedicio® COVID-19 Ag plus Test | Device ID: 2914 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: dedicio® COVID-19 Ag pro Test | Device ID: 2373 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: GeneStore France SAS | Commercial: Detection Expert 1S © SARS CoV-2 kit | Device ID: 2699 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Appolon Bioteck | Commercial: Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) | Device ID: 514 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR) | Device ID: 33 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genetron | Commercial: Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) | Device ID: 722 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: Dia Sure COVID-19 Antigen Rapid Test Device | Device ID: 2060 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc. | Commercial: Dia Sure COVID-19 Antigen Rapid Test Device | Device ID: 2382 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc. | Commercial: Dia-CV19-1 SARS-CoV-2 OneStep RT-PCR Kit (S-Gene) | Device ID: 1121 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc. | Commercial: Dia-CV19-2 SARS-CoV-2 OneStep RT-PCR Kit (S-/ORF1ab-Gene) | Device ID: 540 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagen Biotechnologic Systems Inc. | Commercial: Dia-CV19-3 SARS-CoV-2 Direct OneStep RT-PCR Kit (S-/ORF1ab-Gene) | Device ID: 1122 | Method: RT-PCR | Target: Nucleic acid | Format: 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 |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgA | Device ID: 2477 | Method: CLIA | Target: IgA | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgG | Device ID: 2463 | Method: CLIA | Target: Antibody, IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 NCP IgM | Device ID: 2464 | Method: CLIA | Target: IgM | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: DIA.PRO Diagnostic Bioprobes Srl | Commercial: DIA.CHEMILUX SARS-CoV-2 Spike/RBD Ab | Device ID: 2478 | Method: CLIA | Target: IgG | Format: Fully automated (robot) | Go to details |
| CE Marking: Yes | Manufacturer: Next Pharma Inc. | Commercial: DiaCarta's QuantiVirusTMSARS-CoV-2 Test | Device ID: 295 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: Diagnostic Automation, Inc. SARS-CoV-2 RT-PCR Kit | Device ID: 1194 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2 | Device ID: 1609 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Novatech | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 | Device ID: 1582 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co. Ltd. | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 | Device ID: 440 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) | Device ID: 2167 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold) | Device ID: 2178 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) | Device ID: 879 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnoligies | Commercial: Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal AmplificationReal Time Fluorescence Assay) | Device ID: 2600 | Method: Other | Target: Nucleic acid | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 2096 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 1274 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: Diagnostic kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) | Device ID: 2487 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: mosaiques diagnostics GmbH | Commercial: DiaPat-CoV-50 | Device ID: 2407 | Method: Other | Target: | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ COVID-19 (N, ORF1a) Detection Kit | Device ID: 2493 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ Flu A/B & SARS-CoV-2 Detection Kit | Device ID: 2944 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit | Device ID: 376 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ RV16 Detection Kit (with SARS-CoV-2) | Device ID: 5786 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ SARS-CoV-2 (N, ORF1a, RdRp) Fast Detection Kit | Device ID: 2945 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: DIAQUICK COVID-19 Ag Cassette | Device ID: 1375 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: Diaquick Covid-19 IgG/IgM | Device ID: 1055 | 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