CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
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: AMEDA Labordiagnostik GmbH | Commercial: AMP Rapid Test SARS-CoV-2 Ag | Device ID: 1304 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) | Device ID: 2936 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER COVID-19 Neutralizing Antibody Rapid Testing kit (Colloidal Gold) | Device ID: 2873 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: AMPER Inc. | Commercial: AMPER RSV Antigen Rapid Test (Colloidal Gold) | Device ID: 2870 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: AndLucky SARS-CoV-2 Antigen Anterior Nasal Rapid Test (minimal invasive) | Device ID: 1842 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: 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: Beijing Bohui Innovative Biotechnology Co. Ltd. | Commercial: Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit | Device ID: 2046 | Method: Immunochromatography | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: Yes | Manufacturer: Aripa Biotec GmbH | Commercial: Anti-SARS-CoV-2-Multi-Antikörper IgG/Nab-Test (IgG-Antikörper/neutralisierende Antikörper) (LFIA) | Device ID: 2633 | Method: Immunochromatography | Target: Antibody, IgG | Format: Automated, 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: Z Biotech Inc. | Commercial: AnyLab COVID-19 Ag Test Kit | Device ID: 2599 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: AQ+ COVID-19 Ag Rapid Test | Device ID: 3084 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: AQ+ COVID-19 Ag Rapid Test | Device ID: 3098 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Aquila Healthcare Limited | Commercial: AQUILAVIE ® SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | Device ID: 5727 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: AQUILAVIE ® SARS-CoV-2 Ag Self-test Kit (Nasal Swab) | Device ID: 3041 | Method: Immunochromatography | Target: | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: AQUILAVIE ® SARS-CoV-2 Ag Self-test Kit (Saliva) | Device ID: 3043 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: Aria COVID-19 Ag Rapid Test | Device ID: 1853 | 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: Artron Laboratories Inc. | Commercial: Artron COVID-19 Antigen Test | Device ID: 1618 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Asterion Otel İnşaat Bilişim Medikal Maden Tic. Ltd. Şti. | Commercial: As-check | Device ID: 2454 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: Asan Easy Test COVID-19 Ag | Device ID: 1654 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: Microgenics Corporation | Commercial: ASAPath COVID-19 Antigen Rapid Test | Device ID: 2179 | Method: Immunochromatography | Target: Antigen | Format: Manual, 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: Biobase Diagnostic Technology (Shandong) Co. Ltd. | Commercial: BIOBASE COVID-19 Antigen Rapid Test (Self-testing) | Device ID: 3112 | 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: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 Ag | Device ID: 1962 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: RapiGEN Inc. | Commercial: BIOCREDIT COVID-19 Ag Test Nasal | Device ID: 1963 | 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: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: BioGerm SARS-CoV-2 Antigen Self Test | Device ID: 3039 | 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: 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: BioSpeedia® Covid-19 Nasal AG test BSD_521 | Device ID: 2503 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX AUTOTEST ANTIGENIQUE COVID-19 Ag | Device ID: 2965 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: BIOSYNEX S.A. | Commercial: BIOSYNEX AUTOTEST ANTIGENIQUE COVID-19 Ag+ | Device ID: 2964 | 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: 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: 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: 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: 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: Inzek International trading | Commercial: Biozek covid-19 Antigen Rapidtest BCOV-802 | Device ID: 1987 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Boditech Quick™ COIVD-19 Ag | Device ID: 2413 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co. Ltd. | Commercial: BOH-180 Fluorescent Immunoassay Analyzer | Device ID: 2694 | Method: Immunochromatography | Target: Antibody, Antigen | Format: Near POC / POC, Semi-automated | Go to details |
CE Marking: Yes | Manufacturer: Core Technology Co. Ltd. | Commercial: Canea COVID-19 Antigen Speichel Selbsttest | Device ID: 2505 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
CE Marking: Yes | Manufacturer: Access Bio Inc. | Commercial: CareStart(TM) COVID-19 Antigen | Device ID: 2572 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
CE Marking: Yes | Manufacturer: Access Bio Inc. | Commercial: CareStart(TM) COVID-19 IgM/IgG | Device ID: 2573 | Method: Immunochromatography | Target: Antibody, IgG, IgM | 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