| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Ichroma COVID-19, viral Antigen | Device ID: 107 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 Ag | Device ID: 1990 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 nAb | Device ID: 2398 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 SP/NP IgG | Device ID: 2784 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Bright Line Research | Commercial: Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test | Device ID: 109 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test | Device ID: 1236 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid) | Device ID: 1684 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 IgG/IgM Rapid Test Device | Device ID: 2033 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 110 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag | Device ID: 1647 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CALTH Inc. | Commercial: AllCheck COVID19 Ag Nasal | Device ID: 2691 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CAMP MEDICA DISTRIBUTION | Commercial: See Now Coronavirus nCoV antigen test | Device ID: 1999 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Camtech | Commercial: Camtech COVID-19 Rapid Test Kit | Device ID: 111 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Camtech | Commercial: COVID-19 Viral Antigen Test Kit | Device ID: 1237 | 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: Canary Global Inc. | Commercial: SARS-CoV-2 Ultra Rapid Mobile Antigen Test | Device ID: 2547 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CAS-Envision | Commercial: SARS-CoV-2 Neutralizing Antibodies Test Kit | Device ID: 2788 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cell ID Pte Ltd. | Commercial: Smart COVID-19 IgM/IgG RDT | Device ID: 838 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cellex Inc. | Commercial: Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test | Device ID: 116 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CerTest Biotec | Commercial: CerTest SARS-CoV-2 | Device ID: 1173 | Method: | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP COVID19-INF A/B-RSV MULTI RAPID TEST KIT | Device ID: 5817 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASAL ANTIGEN RAPID TEST | Device ID: 2696 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECK UP SARS-COV-2 NASOPHARYNGEAL ANTIGEN TEST | Device ID: 2746 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CheckUp COVID-INF A/B-RSV COMBO RAPID NASAL TEST KIT | Device ID: 5820 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Cesna Biyoteknoloji Araştırma Geliştirme Laboratuvar Sist.İnş.Müh.Dan.San.Tic.Ltd.Şti. | Commercial: CHECKUP COVID-INF A/B-RSV-ADENO RAPID TEST KIT | Device ID: 5832 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changchun WanCheng Bio Electron Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2934 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changsha Sanji Bio-technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Method) | Device ID: 2990 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changsha Sinocare Inc. | Commercial: SARS-CoV-2 Antibody Test Strip | Device ID: 460 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changsha Sinocare Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) | Device ID: 2365 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Biowin COVID-19 Antigen Nasal Test (Self-test) | Device ID: 3148 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) (For Nasal) | Device ID: 2766 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)（For Nasal) | Device ID: 2641 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Changzhou Biowin Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)（For Saliva)） | Device ID: 2749 | Method: Immunochromatography | Target: Antigen | 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: 2588 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | 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: Chastru Biotech Limited | Commercial: COVID-19 Antigen Test Cassette | Device ID: 3966 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Chembio Diagnostic Systems | Commercial: DPP COVID-19 IgM/IgG System | Device ID: 669 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: CHIL Medical Supplies Ltd. | Commercial: CHiL COVID-19 IgG/IgM Rapid Test cassette | Device ID: 1098 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi | Commercial: CHIL COVID-19 Antigen Rapid Test | Device ID: 3864 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi | Commercial: CHIL COVID-19 Antigen Rapid Test (Nasal / Nasopharyngeal / Oropharyngeal Swab-Casette) | Device ID: 1691 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 2031 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit | Device ID: 1939 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit (IgG) | Device ID: 1944 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit (IgM) | Device ID: 1941 | Method: Immunochromatography | Target: IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antibody Rapid Test Kit (QDs) | Device ID: 1940 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit (Swab) | Device ID: 1938 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit(Swab) | Device ID: 1937 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: iSIA | Device ID: 2056 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing M&D Biotechnology Co. Ltd. | Commercial: 2019-nCoV Antigen Test Kit | Device ID: 2150 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing Novegent Biotech Company Limited | Commercial: Novegent COVID-19 Antibodies Rapid Test Kit | Device ID: 1185 | Method: Immunoassay | Target: Antibody | 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