CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: ADALTIS srl | Commercial: RAPiDgen SARS-CoV-2 Ag Test | Device ID: 2896 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ADS Biotec Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Device ID: 2448 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: AEHEALTH LIMITED | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2676 | Method: | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AESKU.DIAGNOSTICS GmbH & Co. KG | Commercial: AESKU.RAPID SARS-CoV-2 | Device ID: 2108 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 Antigen Test | Device ID: 2130 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AIETech Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (AIE Fluorescence Immunochromatography) | Device ID: 3036 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 3022 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Immunochromatography) | Device ID: 3016 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Saliva) | Device ID: 3023 | Method: Immunochromatography | Target: Antigen | 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: Aikang Diagnostics Co. Ltd. | Commercial: COVID-19 Antigen Test Kit(Nasal/Nasopharyngeal/Oropharyngeal/Saliva) | Device ID: 3024 | Method: Immunochromatography | Target: Antigen | 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: ALLUM SRL | Commercial: DAILY TAMPON | Device ID: 1852 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: 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: Amedica SA | Commercial: Amela Covid-19 Antigen test | Device ID: 829 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | 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 RSV Antigen Rapid Test (Colloidal Gold) | Device ID: 2870 | Method: Immunochromatography | Target: Antigen | 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: AMPER Inc. | Commercial: SC2Flu Triplex Fast Test (Colloidal Gold) For SARS-CoV-2 & influenza A/B antigens | Device ID: 2872 | 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 Antigen Device (Anterior Nasal Swab) | Device ID: 2605 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: COVID-19 Antigen ELISA | Device ID: 1280 | Method: ELISA | Target: Antigen | Format: Automated, Manual | 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 | 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) 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 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: 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: 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: 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 Flu/COVID-19 Ag Combo | Device ID: 1761 | Method: Immunochromatography | Target: Antigen | 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