CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: SARS-COV-2/Influenza A&B Rapid Antigen Test | Device ID: 1777 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1764 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit - Saliva (Colloidal Gold) | Device ID: 1766 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Kaya17 Inc. | Commercial: nCoVega Saliva-Based Rapid Antigen COVID19 Test | Device ID: 2779 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: KitL&H Biotech Limited | Commercial: COVID-19 Antigen Rapid Test | Device ID: 1596 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Koch Biotechnology (Beijing) Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 2038 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Labnovation Technologies Inc. | Commercial: SARS-CoV-2 Antigen Influenza A B Rapid Test Kit(Immunochromatography) | Device ID: 3936 | Method: Immunochromatography | Target: Antigen | Format: Lab-based | Go to details |
CE Marking: Yes | Manufacturer: Labnovation Technologies Inc. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | Device ID: 1266 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Laipac Technology Inc. | Commercial: LooK SPOT | Device ID: 1667 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay) | Device ID: 1648 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lansion Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Test Kit (DryColorLatex Immunoassay) | Device ID: 2818 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LiClear Biotech (Hangzhou) Co., Ltd | Commercial: SARS-COV-2 Nucleocapsid (N) Antigen Rapid Test Cassette | Device ID: 3973 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lifecosm Biotech Limited | Commercial: COVID-19 Antigen Test Cassette | Device ID: 2866 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lifotronic Technology Co. Ltd. | Commercial: Antigen Rapid Test Ag SARS-CoV-2 | Device ID: 1592 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Liming Bio-Products Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device | Device ID: 263 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Linkcare Health Services (Diagnos BT) | Commercial: Covid-19 Antigen Test Kit (Colloidal Gold) | Device ID: 1353 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LOMINA AG | Commercial: COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay) | Device ID: 678 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Sperbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX Selftest | Device ID: 3678 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX Selftest | Device ID: 4070 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2 Antigen LTX test | Device ID: 2560 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Lomina Superbio a.s. | Commercial: Lomina SARS-CoV-2+ Influenza A/B Antigen LTX Test | Device ID: 4147 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LT Biotech JSC | Commercial: COVID19AgLTFLOW | Device ID: 2094 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag LLB | Device ID: 2654 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag Nasal LLB | Device ID: 2668 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag NP LLB | Device ID: 2670 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LUCA AICELL Inc. | Commercial: LUCA NK COVID-19 Ag Saliva LLB | Device ID: 2669 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-CoV-2 Ag Test | Device ID: 1268 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: LumiraDx SARS-CoV-2 Ag Ultra | Device ID: 3836 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: LumiraDx UK Ltd. | Commercial: SARS-CoV-2 Antigen Test | Device ID: 1146 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Maccura Biotechnology Co. Ltd. | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method | Device ID: 1917 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Macrogen | Commercial: AxenTM COVID-19 Ag RAPID | Device ID: 2125 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Manufactured by Eon Biotechnology Limited | Commercial: EONBT COVID-19 ANTIGEN-SALIVA | Device ID: 2161 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: möLab | Commercial: mö-screen Corona Antigen Test | Device ID: 1190 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MED TRUST Handelsges.m.b.H. | Commercial: Wellion SARS-CoV-2 PLUS ANTIGEN Rapid Test | Device ID: 2162 | Method: Immunochromatography | Target: Antigen | Format: 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: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: Flu A/Flu B/SARS-CoV-2 Antigen (GICA) | Device ID: 1713 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen (GICA) | Device ID: 1711 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Medifood Hungary Innovation Kft. | Commercial: MediDia COVID-19 Ag | Device ID: 2973 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MEDsan GmbH | Commercial: MEDsan SARS-CoV-2 Antigen Rapid Test | Device ID: 1180 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MEDsan® GmbH | Commercial: MEDsan® SARS-CoV-2 Ag Duo | Device ID: 3954 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: Meril Diagnostics Pvt Ltd. | Commercial: COVIFIND COVID-19 Antigen Self Test | Device ID: 2923 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: MERISCREEN COVID-19 Antigen Detection Test | Device ID: 2582 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Merlin Biomedical (Xiamen) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2029 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Metas Biomedical Inc. | Commercial: ImmTek COVID-19 Antigen Rapid Test | Device ID: 1928 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: MEXACARE GmbH | Commercial: MEXACARE COVID-19 Antigen Rapid Test | Device ID: 1775 | Method: Chromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Michael Bubolz GmbH | Commercial: Vibamat | Device ID: 4148 | Method: Immunoassay | Target: Antigen | Format: Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: MiCo Biomed Co. Ltd. | Commercial: VERI-Q COVID-19 Ag Rapid Test | Device ID: 2792 | 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