| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: REFGEN BİYOTEKNOLOJİ ANONİM ŞİRKETİ | Commercial: RefKit SARS-CoV-2 Multiplex qPCR Assay | Device ID: 2926 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Finecare™ 2019-nCoV RBD Antibody Test | Device ID: 2925 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Meril Diagnostics Pvt Ltd. | Commercial: COVIFIND COVID-19 Antigen Test | Device ID: 2924 | Method: Immunochromatography | 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: 1drop Inc. | Commercial: 1copy™ COVID-19 MDx Kit Professional | Device ID: 2921 | Method: LAMP | Target: | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19 qPCR 4plex Kit | Device ID: 2920 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19/FluA/FluB/RSV qPCR Kit | Device ID: 2919 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19 qPCR Triplex Kit | Device ID: 2918 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: 1drop Inc. | Commercial: 1copy™ COVID-19 qPCR Multi Kit | Device ID: 2917 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Philosys | Commercial: SoluM COVID-19 Ag Neutralizing Antibody | Device ID: 2916 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PentaBase | Commercial: CoviDetect™ COVID-19 Multiplex RT-qPCR Assay | Device ID: 2915 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: dedicio® COVID-19 Ag plus Test | Device ID: 2914 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Molbio Diagnostics Private Limited | Commercial: Truenat® COVID-19 | Device ID: 2913 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | 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: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) (Anterior Nasal Swab) | Device ID: 2910 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: 2909 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | 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: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal | Device ID: 2907 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BluSense Diagnostics ApS | Commercial: ViroTrack Sero COVID-19 Total Ab | Device ID: 2906 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Medusa19 Life Sciences | Commercial: MeduFlow | Device ID: 2905 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Yunrui Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Testing kit(Colloidal Gold) | Device ID: 2904 | Method: ELISA | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Coorporation | Commercial: Savanna RVP-4 panel assay | Device ID: 2903 | Method: RT-PCR | Target: Nucleic acid | Format: Fully automated (robot), 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: Synbiotik Biotechnology | Commercial: SeroCap Anti-SARS-CoV-2 Neutralizing Kit | Device ID: 2901 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019-nCoV) RT-qPCR Detection Kit | Device ID: 2900 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: K.K. Mirai Genomics | Commercial: LifePad Analyzer | Device ID: 2899 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: K.K. Mirai Genomics | Commercial: Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method | Device ID: 2898 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Bigfish Bio-tech Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2 ) Antigen Rapid Test(Colloidal Gold) | Device ID: 2897 | Method: Immunochromatography | Target: Antigen | Format: 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: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold） | Device ID: 2895 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun Covid-19 Ag CARD | Device ID: 2894 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Diagnostics Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette (Saliva) | Device ID: 2893 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Diagnostics Biotechnology Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette(Nasopharyngeal/Oropharyngeal /Nasal) | Device ID: 2892 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: GLINE-2019-nCoV Ag (Self-test) | Device ID: 2891 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi Flu & COVID-19 Antigen Duo | Device ID: 2890 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal gold method) | Device ID: 2889 | Method: Immunoassay | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2-Virus-Antigen-Testkit (Kolloidales Gold) | Device ID: 2888 | Method: Immunoassay | Target: Antigen | Format: Manual, 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)-Nasopharyngeal | Device ID: 2887 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou GENESIS Biodetection and Biocontrol Co. Ltd. | Commercial: KaiBiLi COVID-19 Antigen Pro | Device ID: 2885 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Synbiotik Biotechnology | Commercial: Q-Check Rapid Lateral Flow Assay for SARS-CoV-2 Antigen Detection | Device ID: 2884 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Becton Dickinson | Commercial: BD SARS-CoV-2/Flu for BD Max Systems | Device ID: 2883 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Cassette(Nasal Swab)(Self-testing) | Device ID: 2882 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) | Device ID: 2881 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hain Lifescience a Bruker company | Commercial: FluoroType® SARS-CoV-2 plus | Device ID: 2880 | Method: RT-PCR | Target: Nucleic acid | Format: Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Abingdon Health Plc | Commercial: AbC-19 Semi-Q Rapid Test | Device ID: 2879 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Greylynx Biotech Co. Ltd. | Commercial: NADAL SARS-COV-2 Ag Rapid Test | Device ID: 2878 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ä°DÄ°L BÄ°OTECH ARAÅžTIRMA SAN. VE TÄ°C. Ltd. ÅžTÄ°. | Commercial: RevoDx SARS-CoV-2 qPCR Kit | Device ID: 2877 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Excalibur Healthcare Services Limited | Commercial: RAPID SARS-COV-2 ANTIGEN SCREENING TEST CARD | Device ID: 2876 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: /COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal - self testing device | Device ID: 2875 | Method: Immunoassay | Target: Antigen | Format: Manual | 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 |
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