| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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 Device (nasal swab) (self-test) | Device ID: 3027 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: 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: Beijing Unidiag Technology Inc. | Commercial: Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 3033 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) | Device ID: 2044 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold) | Device ID: 2808 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Double Antigen Sandwich Colloidal Gold Immunochromatography) | Device ID: 2048 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay) | Device ID: 2047 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | 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 Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) | Device ID: 2841 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: Novel Coronavirus Neutralizing Antibody Rapid Test Kit | Device ID: 2040 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold) | Device ID: 2871 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Novel Coronavirus(SARS-CoV-2) Neutralizing AntibodiesTest (Up-converting Phosphor Immunochromatographic Technology) | Device ID: 2809 | Method: Immunochromatography | Target: Antibody | 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）（self-test） | Device ID: 3116 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: OFM Medical | Commercial: OFM GmbH | Device ID: 2202 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Zhongke Lanhai Biotechnology Co. Ltd. | Commercial: OJABIO SARS-CoV-2 Antigen Detection Test Kit (Colloidal Gold Method) | Device ID: 1575 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: One Step SARS-CoV-2(COVID-19) Antigen Rapid Test (Oral Fluid) | Device ID: 3003 | Method: Immunochromatography | 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: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 Ag Saliva | Device ID: 2637 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Delta Chemie Biotechnology SAS | Commercial: OneCheck Covid-19 IgG Spike RBD | Device ID: 2638 | Method: Immunochromatography | Target: IgG | Format: 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: Unimed International Inc. | Commercial: OnSight™ - COVID-19 IgG/IgM Combo Test | Device ID: 2133 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unimed International Inc. | Commercial: OnSight™- COVID-19 NAb Quantitative Test | Device ID: 2135 | Method: Immunochromatography | Target: IgG | 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: 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-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 NEUTRALIZING ANTIBODY Rapid Test Device - CO_04 (Check vaccination coverage) | Device ID: 2496 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 Ag | Device ID: 321 | Method: Immunochromatography | 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: Immunochromatography | 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: Primer Design Limited | Commercial: PathFlow™ COVID-19 Rapid Antigen PRO | Device ID: 2782 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Primer Design Limited | Commercial: PathFlow™ COVID-19 Rapid Antigen PRO | Device ID: 25543 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | 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: PCL Inc. | Commercial: PCL COVID19 Ag Gold | Device ID: 2243 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL SELF TEST - COVID19 Ag | Device ID: 3694 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Labormed Tıbbi Ãœrünler San Ve Tic Ltd. ÅžTÄ° | Commercial: Pekit Covid-19 Rapid (Hızlı) Antigen Test | Device ID: 3010 | Method: Immunochromatography | Target: Antigen | Format: 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: Zhejiang Aibu Biotech Co. Ltd. | Commercial: Pluridiag SARS-COV-2 Ag Rapid Test | Device ID: 2780 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: Polonord Adeste Srl | Commercial: POLOFLUOR 2 | Device ID: 2583 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: LABORATOIRE SALEM | Commercial: Précisio TEST COVID-19 ANTIGENE | Device ID: 3967 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Immundiagnostik AG | Commercial: PreventID ® SARS-CoV-2-Antigen | Device ID: 2815 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Cold Spring Biotech Corp. | Commercial: Q-Check COVID-19 Antigen Rapid Test | Device ID: 3011 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: Q-Sens® COVID-19 Ag | Device ID: 3103 | Method: Immunochromatography | Target: Antigen | Format: 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: Diacarta Inc. | Commercial: QuantiVirus SARS-CoV-2 Antigen Rapid Test | Device ID: 3001 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: QuickVue SARS Antigen FIA | Device ID: 2269 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: M.I.Tech Co. Ltd. | Commercial: RAPICHECK COVID-19 Ag | Device ID: 2928 | Method: Immunochromatography | 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 |
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