CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co. Ltd. | Commercial: COVID-19 Test Kit (Colloidal Gold Method)(Nasal Swab) | Device ID: 2609 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 2096 | Method: Immunochromatography | Target: Antigen | Format: | 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: BN Santé | Commercial: SARS-CoV-2 Antigen Rapid test | Device ID: 1964 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2203 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
CE Marking: Yes | Manufacturer: Pharmaline AS | Commercial: RAPIDIGEN COVID19 AG IMMUNOASSAY | Device ID: 1823 | Method: Immunochromatography | Target: Antigen | Format: Automated | Go to details |
CE Marking: Yes | Manufacturer: Hubei Jinjian Biology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit | Device ID: 1759 | Method: Immunochromatography | Target: Antigen | Format: Automated | 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: Shenzhen Kingfocus Biomedical Engineering Co. Ltd. | Commercial: COVID-19 Antigen Detection Kit(Quantum Dots-Based Immunofluorescence Chromatography) | Device ID: 2941 | Method: Immunochromatography | Target: Antigen | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal (self-test) | Device ID: 2658 | Method: Immunochromatography | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: Andlucky™ COVID-19 Antigen Rapid Test | Device ID: 1296 | Method: Immunochromatography | Target: Antigen | Format: Lab-based | 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: 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: 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: Baicare(Tianjin) Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2602 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2090 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
CE Marking: Yes | Manufacturer: Weihai Dishang Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit (LFIA) | Device ID: 2804 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | 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: Pierenkemper GmbH | Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 / Saliva | Device ID: 2197 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co.,LTD | Commercial: COVID-19 /Flu A&B /RSV Ag Rapid Test Cassette (Swab) | Device ID: 25624 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. | Commercial: COVID-19 Ag Rapid Test Kit | Device ID: 3153 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Livzon Rapid Test for SARS-CoV-2 Antigen (Lateral Flow) | Device ID: 1441 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: ADALTIS srl | Commercial: RAPiDgen SARS-CoV-2 Ag Test | Device ID: 2896 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay) | Device ID: 2166 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test | Device ID: 4054 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test | Device ID: 1457 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Device ID: 1865 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Lollipop (Saliva) | Device ID: 4050 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | 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: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 & Influenza A/B Ag Combo Rapid Test | Device ID: 2594 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Strip | Device ID: 4045 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, 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: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | Device ID: 3086 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: Actim Oy | Commercial: Actim SARS-CoV-2 | Device ID: 2245 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Acura Kliniken Baden-Baden GmbH | Commercial: Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit | Device ID: 2459 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Xiamen Zhongsheng Langjie Biotechnology Co. Ltd. | Commercial: AgiAccu COVID-19 Antigen Test Cassette | Device ID: 2510 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive) | Device ID: 1843 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Z Biotech Inc. | Commercial: AnyLab COVID-19 Ag Nasal Test Kit | Device ID: 2912 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: Asan Easy Test Flu/COVID-19 Ag Combo | Device ID: 1761 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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: Inzek International trading | Commercial: Biozek covid-19 Antigen Rapidtest BCOV-502 | Device ID: 1988 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Celltrion DiaTrust ™– Covid-19 Ag Rapid Test | Device ID: 2635 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: CORMAY | Commercial: CORMAY RAPID SARS-CoV-2 ANTIGEN TEST KIT | Device ID: 1810 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Antigen - Oral Fluid | Device ID: 1934 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Antigen - Swab Specimen | Device ID: 1935 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Xiamen Biotime Biotechnology Co. Ltd. | Commercial: COVID-19 Ag & Flu A/B Combo Self Test | Device ID: 5720 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co.,Ltd. | Commercial: COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay) | Device ID: 3270 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Detection Kit (Colloidal Gold) | Device ID: 2636 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Pro-med (Beijing) Technology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Detection Kit (Colloidal Gold) | Device ID: 2482 | 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