| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) - Nasal Swab | Device ID: 1815 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold) | Device ID: 1736 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit | Device ID: 510 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deepblue Medical Technology Co.,Ltd | Commercial: COVID-19 (SARS-CoV-2) Neutralizing Antibody (Double Antigen Sandwich) Test Kit (Colloidal Gold) | Device ID: 2189 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deepblue Medical Technology Co.,Ltd | Commercial: COVID-19 (SARS-CoV-2) Neutralizing Antibody IgG Test Kit (Colloidal Gold) | Device ID: 2198 | Method: Immunochromatography | Target: IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Formaster Biosci Co., Ltd. | Commercial: New Coronavirus (COVID-19) Antigen Rapid Test | Device ID: 2089 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Hua Pei Biotechnology Co., Ltd. | Commercial: COVID-19 Virus Antigen Detection Kit（Fluorescence Immunochromatography Assay） | Device ID: 2375 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Confirmation RT-Qpcr | Device ID: 511 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AniCon Labor GmbH | Commercial: Kylt SARS-CoV-2 Screening RTU RT-qPCR | Device ID: 512 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Anitoa | Commercial: 2019 New Coronavirus (2019-nCoV) Test Kit | Device ID: 895 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Anlong Gene | Commercial: 2019-nCov nucleic acid (Fluorescence PCR) | Device ID: 888 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | 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: Anlong Gene | Commercial: nConV-19 Nucleic Acid qPCR Kit | Device ID: 35 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ansh Labs | Commercial: SARS-CoV IgG ELISA | Device ID: 914 | Method: ELISA | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ansh Labs | Commercial: SARS-CoV IgM ELISA | Device ID: 915 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: AnTaimmu BioMed | Commercial: COVID-19 Antigen Rapid Test (Vstrip) | Device ID: 1451 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AnteoTech Ltd | Commercial: SARS-CoV-2 Ag RDT | Device ID: 2376 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: AnyGenes | Commercial: Efficient 2019-nCOV detection kit, one step RT-qPCR (N1 & N2) | Device ID: 513 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: APLUS Diagnostics Laboratuvar San.Tic.A.S. | Commercial: SMARAPIDTEST | Device ID: 1344 | Method: Immunoassay | Target: Antibody, Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Apollo Biomedical LLC | Commercial: Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor) | Device ID: 1289 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Applied BioCode | Commercial: BioCode SARS CoV-2 Assay kit | Device ID: 1399 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Applied Biological Materials Inc | Commercial: GenomeCoV9 Detection Kit | Device ID: 916 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Applied Biological Materials Inc | Commercial: GenomeCov9 IgM/IgG Rapid Test Kit | Device ID: 917 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Applied Biomedical, LLC | Commercial: Confidence COVID-19 Rapid Test | Device ID: 767 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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: No | Manufacturer: Aptamer Group Ltd | Commercial: Adx SARS Cp V-2 Virus Antigen Rapid Point of Care Test | Device ID: 663 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ArcDia International Ltd | Commercial: mariPOC SARS-CoV-2 | Device ID: 768 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ArcDia International Oy Ltd | Commercial: mariPOC Quick Flu+ | Device ID: 2079 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ArcDia International Oy Ltd | Commercial: mariPOC Respi+ | Device ID: 2078 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Aripa Biotec GmbH | Commercial: COVID-19-N-Antigen Schnelltest SARS-CoV-2 | Device ID: 2169 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ARISTA Biotech Pte. Ltd | Commercial: ARISTA COVID-19 Antigen Rapid Test | Device ID: 1926 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ARROW DIAGNOSTICS SRL IT | Commercial: Allplex SARS-CoV-2 Assay | Device ID: 1128 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Artron Laboratories Inc | Commercial: Artron COVID-19 Antigen Test | Device ID: 1618 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Artron Laboratories Inc | Commercial: Artron COVID-19 IgM/IgG Antibody Test | Device ID: 1729 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: ARUP Laboratories | Commercial: COVID-19 | Device ID: 702 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 Ag | Device ID: 1654 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test COVID-19 IgG/IgM | Device ID: 1760 | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical CO., LTD | Commercial: Asan Easy Test Flu/COVID-19 Ag Combo | Device ID: 1761 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co., Ltd. | Commercial: Asan Easy Test COVID-19 Ag | Device ID: 2251 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: asdf | Commercial: asdf | Device ID: 2360 | Method: Digital-PCR | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AssayGenie | Commercial: COVID-19 CE IVD qPCR assay | Device ID: 891 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Assurance Scientific Laboratories | Commercial: SARS-COV-2 PANEL | Device ID: 1400 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co., Ltd | Commercial: COVID-19 Antigen Saliva Test Kit | Device ID: 2037 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 & Influenza A/B Antigen Combo Test Device | Device ID: 1371 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 & Influenza A/B Nucleic Acid Combo Test | Device ID: 1373 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 & M. pneumoniae Antigen Combo Test Device | Device ID: 1372 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Device (Nasal Swab) | Device ID: 2076 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 Antigen Saliva Test Kit | Device ID: 1579 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 664 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 Neutralizing Antibody FIA | Device ID: 1577 | Method: Immunoassay | Target: Antibody | Format: Lab-based | 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