CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
---|---|---|---|---|---|---|---|
CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 Antigen ELISA Kit | Device ID: 449 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 Antigen Rapid Test | Device ID: 448 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS CoV-2 IgM ELISA Kit | Device ID: 447 | Method: ELISA | Target: Antibody, IgM | Format: Lab-based | Go to details |
CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona Antigen ELISA Kit | Device ID: 446 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona IgM ELISA Kit | Device ID: 450 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: No | Manufacturer: Zalgen Labs LLC | Commercial: ReSARS Pan-Corona Rapid Test | Device ID: 445 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
CE Marking: No | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: AndLucky SARS CoV-2 Antigen Rapid Test, Anterior Nasal Check (minimal-invasiv) | Device ID: 2008 | Method: Immunoassay | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Zhengzhou Fortune Bioscience Co. Ltd. | Commercial: IgG/IgM Antibody Rapid Test Kits (Colloidal Gold Immunochromatography method) | Device ID: 699 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
CE Marking: No | Manufacturer: Zhuhai Haitai Biological Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV)/Flu A/Flu B Real-time Multiplex RT-PCR Kit (manual & automated lab-based) | Device ID: 455 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Diagnostic Kit for Nucleic Acid to nCoV-2019 (PCR- Fluorescence Probe) | Device ID: 457 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
CE Marking: No | Manufacturer: Zugotech Labs Ltd. | Commercial: Zugotech COVID-19 IgM/IgG Rapid Test | Device ID: 458 | Method: Immunoassay | Target: Antibody | 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