CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Bakter Medical s.r.o. | Commercial: Saligen | Device ID: 1782 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD Veritor™ System for Rapid Detection of SARS CoV 2 | Device ID: 1065 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Abace Biology Co. Ltd. | Commercial: COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1281 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit | Device ID: 2769 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Hotgen Biotech Co. Ltd. | Commercial: Coronavirus (2019-nCoV)-Antigentest | Device ID: 2807 | 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: 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: SARS-CoV-2 and Flu A/B Antigen Combo Rapid Test (Colloidal Gold) | Device ID: 2810 | 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 Kewei Clinical Diagnostic Reagent Inc. | Commercial: COVID19 Antigen Rapid Test Kit | Device ID: 1778 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1790 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: 2019-nCoV antigen, Influenza A virus antigen, Influenza B virus antigen detection kit (colloidal gold immunochromatography) | Device ID: 3078 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1331 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing North Institute of Biotechnology Co. Ltd. | Commercial: COVID-19 TEST RAPIDO ANTIGENE RICOV4 | Device ID: 2733 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Beijing Savant Biotechnology Co. Ltd. | Commercial: Coronavirus (SARS-Cov-2) N protein Detection Kit (Fluorescence immunochromatography) | Device ID: 76 | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | 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 Wantai Biological Pharmacy Enterprise Co. Ltd. | Commercial: WANTAI SARS-CoV-2 Ag Rapid Test (Colloidal Gold) | Device ID: 1485 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Biobase Diagnostic Technology (Shandong) Co. Ltd. | Commercial: BIOBASE COVID-19 Antigen Rapid Test(Self-Test) | Device ID: 3071 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BioDetect (Xiamen) Biotechnology Co. Ltd. | Commercial: RAPID SARS-COV-2 ANTIGEN TEST CARD (self test) | Device ID: 2902 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Biofeld Diagnostic and Lab Solutions INC. | Commercial: Biofeld Covid-19 Antigen Schnelltest | Device ID: 3504 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BioGnost Ltd. | Commercial: CoviGnost AG Test Device 1x20 | Device ID: 2247 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: BOH-180 Fluorescent Immunoassay Analyzer | Device ID: 2694 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Anterior Nasal Swab | Device ID: 2692 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Quantitative Test (Fluorescence Immunochromatography)-Blood | Device ID: 2693 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2230 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Fluorescence Immunochromatography) | Device ID: 1286 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOLAN HEALTH S.L. | Commercial: COVID-19 Antigen Rapid Test (Colloidal Gold Method) | Device ID: 2519 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Bioneovan Co. Ltd. | Commercial: Bioneovan COVID-19 Antigen Test Kit (Colloidal Gold) | Device ID: 2077 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Biopanda Reagents | Commercial: COVID-19 Rapid Antigen Test | Device ID: 2034 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Bioscience(Tianjin) Diagnostic Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Antigen Rapid Test | Device ID: 2623 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: BioSpeedia COVID19 Nasal Antigen Test BSD_506 | Device ID: 2381 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: BioSpeedia COVID19 Non-Invasive Antigen Test BSD_504 | Device ID: 2379 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BioSpeedia International | Commercial: COVID19Speed-Antigen Test BSD_0503 | Device ID: 2380 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 Ag BSS | Device ID: 1223 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVID-19 Ag+ BSS | Device ID: 1494 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX COVITOP | Device ID: 2947 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay) | Device ID: 25545 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay) | Device ID: 25541 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatographic assay) | Device ID: 5827 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 3487 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 5853 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOTEKE CORPORATION (WUXI) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (anterior nasal swab) | Device ID: 5852 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Biotical Health S.L.U. | Commercial: biotical SARS-CoV-2 Ag Card | Device ID: 2013 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BN Santé | Commercial: SARS-CoV-2 Antigen Rapid test | Device ID: 1964 | Method: Immunochromatography | Target: Antigen | Format: | 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: 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: 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: 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 |
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