| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: Rapid COVID-19 Antigen Test | Device ID: 1735 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc | Commercial: Rapid COVID-19 Antigen Qualitative Test Kit | Device ID: 1182 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Response Biomedical Corp. | Commercial: RAMP COVID-19 Antigen Test | Device ID: 2095 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Corporation | Commercial: QuickVue SARS Antigen Test | Device ID: 2269 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc | Commercial: QuickProfile COVID-19 Antigen Test | Device ID: 1267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lumigenex (Suzhou) Co., Ltd | Commercial: PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2128 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: iXensor | Commercial: PixoTest® POCT COVID-19 Antigen Test | Device ID: 2217 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd | Commercial: PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Device ID: 1264 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Canary Global Inc | Commercial: Pelican COVID-19 Ultra-Rapid Mobile Test | Device ID: 2283 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 Ag Rapid FIA | Device ID: 308 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc | Commercial: PCL COVID19 Ag Gold | Device ID: 1758 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Precision Biosensor | Commercial: PBCheck COVID-19 Ag | Device ID: 2467 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoDetect COVID-19 Ag Qualitative PCR Kit (Compatible with the Automated Extraction System- COMPACT X/XL) | Device ID: 2357 | Method: RT-PCR | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Lateral Flow Test Device | Device ID: 2408 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Fluorescence Immunoassay Kit | Device ID: 2422 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Ag Lateral Flow Test Device | Device ID: 2320 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag (Nasopharyngeal Swab) | Device ID: 2271 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag | Device ID: 1270 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abbott Rapid Diagnostics | Commercial: Panbio Covid-19 Ag Rapid Test | Device ID: 1232 | Method: Other | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd | Commercial: OraWell COVID-19 Ag.Rapid Saliva test DEVICE, CO-07(One Step) | Device ID: 2495 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co.,Ltd. | Commercial: Orawell COVID-19 Ag Rapid Saliva Test Device (CO-07) | Device ID: 2517 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co.,Ltd. | Commercial: Orawell COVID-19 Ag Rapid Saliva Test Device (CO-03) | Device ID: 2500 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech, Inc | Commercial: OnSite COVID-19 Ag Rapid Test | Device ID: 1581 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unimed International, Inc. | Commercial: OnSight™ - COVID-19 Antigen Test | Device ID: 2131 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics, Inc | Commercial: OneStep COVID-19 Antigen RapiCard InstaTest | Device ID: 1195 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 Ag | Device ID: 2088 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech, Inc. | Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | Device ID: 2183 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Bionote, Inc | Commercial: NowCheck COVID-19 Ag Test | Device ID: 1242 | 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: Hangzhou Deangel Biological Engineering Co., Ltd | Commercial: Novel Coronavirus S Glycoprotein Detection Kit | Device ID: 1259 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co., Ltd | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) - Saliva | Device ID: 1798 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co., Ltd | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Device ID: 1870 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Jinwofu Bioengineering Technology Co.,Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit | Device ID: 2072 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva) | Device ID: 1796 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab) | Device ID: 2018 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 1220 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech (Beijing) Co.,ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2278 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing)Co.ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2284 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Realy Tech | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2298 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing) Co.,ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | Device ID: 2331 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co.,Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette | Device ID: 2153 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-Cov-2) Antigen rapid test | Device ID: 1743 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Avioq Bio-Tech Co., Ltd | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold) | Device ID: 1972 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vacure Prelab Medical Technology Co., Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit (Immunochromatography) | Device ID: 2041 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Laihe Biotech Co., Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Testkit (Colloidal Gold | Device ID: 2224 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Medakit Ltd | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 1784 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BN Santé | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 1828 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Norman Biological Technology Co.,Ltd | Commercial: Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) | Device ID: 2506 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: Novel Coronavirus (2019-nCOV) Antigen Rapid Test Cassette (Quantum Dot-based Fluorescence Immunochromatography) | Device ID: 1795 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing WSWY Technology Co.,.Ltd | Commercial: Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Quantum Dot-Based Fluorescence Immunochromatography) | Device ID: 1362 | Method: Immunoassay | Target: Antigen | 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