CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: AIDIAN | Commercial: Acro 2019-nCoV IgG/IgM pikatesti | Device ID: 994 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit(Immunochromatography) | Device ID: 3017 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Akralab | Commercial: 2019nCoV IgG/IgM Rapid test Device | Device ID: 1002 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: DrivenFlow COVID-19 | Device ID: 21 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view PLUS COVID-19 Test | Device ID: 958 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view® PLUS COVID-19 Antigen Test | Device ID: 1678 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alphagen Bio-Technology Co.,Ltd | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 3965 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Alphagen Bio-Technology Co.,Ltd | Commercial: SARS-CoV-2 Antigen Test Kit(Colloidal Gold) | Device ID: 3265 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Amazing Biotech (Shanghai) Co. Ltd. | Commercial: COVID-19 Antigen Sealing Tube Test Strip (Colloidal Gold) | Device ID: 2075 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Amazing Biotech (Shanghai) Co. Ltd. | Commercial: Ultrafast Twinblock 8 Wells Real Time PCR Instrument | Device ID: 4080 | Method: RT-PCR | Target: RNA | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 Ag | Device ID: 1304 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMEDA Labordiagnostik GmbH | Commercial: Rapid Test SARS-CoV-2 Ag | Device ID: 1602 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) | Device ID: 2936 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold) | Device ID: 2873 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: Quadruple Fast Test Pen (Latex) For SARS-CoV-2 & influenza A/B antigens and COVID-19 Neutralizing antibody | Device ID: 3579 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: RSV-SC2-Flu Quadruplex Fast Test (Colloidal Gold) For RSV SARS-CoV-2 & Influenza A/B antigens | Device ID: 5799 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Antigen Device | Device ID: 1203 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV IgG/IgM Device | Device ID: 1048 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: 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: 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) 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 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: 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: 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: 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: 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: 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: 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: 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 |
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: 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 Antigen Nasal Test Kit | Device ID: 2280 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit | Device ID: 3106 | 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& RSV Antigen Nasal Test Kit | Device ID: 5803 | Method: Immunochromatography | 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 Nasal Test Kit | Device ID: 2277 | Method: Immunochromatography | 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 | Device ID: 2270 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 24760 | 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: 2037 | Method: Immunoassay | Target: Antigen | Format: Manual, 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