CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
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: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Rapid Test Slim(Self-Testing) | Device ID: 4052 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: Flowflex SARS-CoV-2 Antigen Saliva Rapid Test Lollipop (Self-Testing) | Device ID: 4051 | Method: Immunochromatography | Target: Antigen | Format: Other | 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: AMPER Inc. | Commercial: RSV-SC2-Flu Quadruplex Fast Test (Colloidal Gold) For RSV SARS-CoV-2 & Influenza A/B antigens | Device ID: 5799 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aripa Biotec GmbH | Commercial: COVID-19-N-Antigen Schnelltest SARS-CoV-2 | Device ID: 2169 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Artron Laboratories Inc. | Commercial: Artron COVID-19 Antigen Self Test | Device ID: 5779 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 & Influenza A/B Antigen Nasal Test Kit | Device ID: 3106 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Assure Tech (Hangzhou) Co. Ltd. | Commercial: COVID-19 Antigen Saliva Test Kit | Device ID: 2037 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Atlas Link Technology Co. Ltd. | Commercial: NOVA Test® SARS-CoV-2 Antigen Home Test Kit | Device ID: 2956 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test (self-test) | Device ID: 3082 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Beijing Easy-Sweet Bio-medical Science and Technology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) | Device ID: 3622 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: 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: Birmingham Biotech Ltd. | Commercial: BHM COVID-19 Antigen Rapid Test | Device ID: 3008 | Method: Immunoassay | 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 |
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: 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: CITEST DIAGNOSTICS Inc. | Commercial: COVID-19 Antigen Test for Self Testing | Device ID: 1476 | Method: Immunoassay | Target: Antigen | Format: 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: Dräger Safety AG & Co. KGaA | Commercial: Dräger COVID-19 Home Test | Device ID: 2647 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Dynamiker Biotechnology(Tianjin) Co. Ltd. | Commercial: Dynamiker SARS-CoV-2 Ag Rapid Test | Device ID: 3995 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: EON Biotechnology Limited | Commercial: EONBT COVID-19 Antigen | Device ID: 2032 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Eternal Material Co.,Ltd. | Commercial: COVID-19 Antigen Rapid Test For Self Test | Device ID: 3453 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Fosun Diagnostics (Shanghai) Co. Ltd. | Commercial: Covid-19 Antigen CARD Kit | Device ID: 4055 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Genes2me Private LTD | Commercial: RapiCov Rapid Antigen Test Kit for COVID‐19 | Device ID: 4072 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Genrui Biotech Inc. | Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (Self-Testing) | Device ID: 4159 | Method: Immunochromatography | Target: Antigen | Format: Manual, Other | Go to details |
CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) (for self-testing) | Device ID: 4088 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-Chek 2019-nCoV Ag Rapid Test Kit (Immunochromatography) | Device ID: 5762 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: V-Chek 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography) | Device ID: 5763 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Weimi Bio-Tech Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 3459 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)-Self-test | Device ID: 2908 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co Ltd | Commercial: SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva) for self testing | Device ID: 4107 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: GSD NovaGen SARS-CoV-2 Ag Rapid Test (Nasal Swab) for self testing | Device ID: 2690 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal Swab) for self testing | Device ID: 2529 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device(Colloidal Gold) | Device ID: 2139 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd. | Commercial: SARS-Cov-2&Influenza A/B Combo Rapid Test Cassette (swab) | Device ID: 3964 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co. Ltd. | Commercial: GENnasal SARS-CoV.2 Antigen Rapid Test | Device ID: 3146 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co. Ltd. | Commercial: Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) | Device ID: 1929 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co.,Ltd, | Commercial: Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) - self-testing | Device ID: 3562 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antigen Test | Device ID: 2484 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Jiangsu Medomics Medical Technology Co., Ltd | Commercial: SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA) | Device ID: 3974 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO. LTD. | Commercial: SARS-CoV-2 Antigen Rapid Test (Self-Testing) (Nasal) | Device ID: 4099 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 |
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