CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Anatolia Geneworks | Commercial: Bosphore Novel Coronavirus (2019-nCoV) Detection Kit | Device ID: 31 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Anbang (Xiamen) Biotechnology Co. Ltd. | Commercial: COVID-19 Hybrid Capture Fluorescence Immunoassay Test | Device ID: 32 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva | Device ID: 2604 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold) | Device ID: 1822 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test(Colloidal Gold) | Device ID: 2239 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Anhui Bessie Biological Technology Co. ,Ltd. | Commercial: COVID- 19 Antigen Rapid Test Kit | Device ID: 4142 | Method: Chromatography | Target: Antigen, IgM | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Anhui Deep Blue Medical Technology Co. Ltd. | Commercial: Colloidal gold strip for SARS-CoV-2 IgG & IgM | Device ID: 34 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: 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) - (Nasal swab/saliva) | Device ID: 1589 | 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) 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 (self-testing) | Device ID: 2750 | 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 Midstream — Saliva | Device ID: 2651 | 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) 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 Deep Blue 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 Deep Blue 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 Formaster Biosci Co. Ltd. | Commercial: New Coronavirus (COVID-19) Antigen Rapid Test (saliva) | Device ID: 2480 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: No | 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: 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: Ant Medical Limited Company | Commercial: Laborant SARS CoV-2 RT-qPCR Kit | Device ID: 3117 | Method: RT-PCR | Target: Nucleic acid | Format: | 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: 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: 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: Aquila Healthcare Limited | Commercial: AQUILAVIE ® SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | Device ID: 5727 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ArcDia International 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 Ltd. | Commercial: mariPOC Respi+ | Device ID: 2078 | Method: Immunoassay | Target: Antigen | Format: Automated, 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: Automated, Near POC / POC | Go to details |
CE Marking: No | Manufacturer: ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ. | Commercial: CoVard Covid-19 Nasal Antigen Test Kit | Device ID: 3568 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: No | Manufacturer: ARDİ MEDİKAL ARAŞTIRMA VE DİAGNOSTİK ÜRÜNLERİ SAN. TİC. LTD. ŞTİ. | Commercial: CoVard Covid-19 Rapid Antigen Test Kit | Device ID: 4000 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aripa Biotec GmbH | Commercial: Anti-SARS-CoV-2-Multi-Antikörper IgG/Nab-Test (IgG-Antikörper/neutralisierende Antikörper) (LFIA) | Device ID: 2633 | Method: Immunochromatography | Target: Antibody, IgG | Format: Automated, Manual | 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: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ArtBioTech LLC | Commercial: ArtTest™ COVID-19 Express Kit | Device ID: 2957 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual, Other | Go to details |
CE Marking: Yes | Manufacturer: Artron Laboratories Inc. | Commercial: Artron COVID-19 Antigen Self Test | Device ID: 5779 | Method: Immunochromatography | Target: Antigen | Format: Other | 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: Immunochromatography | 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 |
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