| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive) | Device ID: 1845 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: COVID-19 IgG IgM Test | Device ID: 1298 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: COVID-19 Antigen Rapid Test | Device ID: 1198 | Method: Immunoassay | Target: Antigen | Format: 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: 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 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: 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: Yes | Manufacturer: ZET medikal tekstil dis tic ltd sti | Commercial: SOFTEC Sars Cov-2 (Covid-19) Antigen Test Kit | Device ID: 2226 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Group | Commercial: COVISCREEN test for detection of IgM/IgG/IgA antibodies | Device ID: 815 | Method: Immunoassay | Target: Antibody, IgG, IgM, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zenum Technologies | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1031 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zekmed | Commercial: Zekmed antigen rapid test cassette (colloidal gold) | Device ID: 1914 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | 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: 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 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 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 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 Antigen ELISA Kit | Device ID: 449 | Method: ELISA | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Z Biotech Inc. | Commercial: AnyLab COVID-19 Ag Test Kit | Device ID: 2599 | Method: Immunochromatography | Target: IgG, IgM, IgA | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Yuno Diagnostics Co., Ltd | Commercial: Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits | Device ID: 444 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: YouSeq Ltd | Commercial: YouSeq SARS-COV-2 qPCR Test | Device ID: 636 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: YD Diagnostics Corp. | Commercial: MolecuTech Real-Time COVID-19 | Device ID: 635 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Yantai Addcare Bio-Tech Limited Company | Commercial: Fully Automated Nucleic Acid Extractor | Device ID: 1897 | Method: Other | Target: Nucleic acid | Format: Fully automated (robot) | Go to details |
| CE Marking: No | Manufacturer: Yantai Addcare Bio-Tech | Commercial: Fully Automated Nucleic Acid Extractor (magnetic beads adsorption) | Device ID: 1898 | Method: Other | Target: Nucleic acid | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd | Commercial: COVID-19 Nucleic Acid Detection Kit (Multiplex Real Time PCR) | Device ID: 443 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Yale New Haven Hospital Clinical Virology Laboratory | Commercial: SARS-CoV-2 PCR test | Device ID: 753 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: Xiamen Zeesan Biotech Co., Ltd | Commercial: SARS-CoV-2 Test Kit | Device ID: 441 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibodies Test | Device ID: 1885 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool) | Device ID: 1887 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test (Saliva) | Device ID: 1886 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) | Device ID: 1884 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 1456 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Wiz Biotech Co., Ltd | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2 | Device ID: 440 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Jiqing Biomedical Technology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) | Device ID: 1588 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Jiqing Biomedical Technology Co. Ltd | Commercial: Gruenbanka SARS-CoV-2 Antigen Testkit | Device ID: 2057 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Hopegen Medical Technology Co.,Ltd | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1996 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co., Ltd | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 2264 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 1278 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd | Commercial: Rapid 2019-nCoV IgG/IgM Combo Test Card | Device ID: 439 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Biotime Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit | Device ID: 438 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Biotime Biotechnology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Qualitative Test | Device ID: 1685 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen AmonMed Biotechnology Co., Ltd | Commercial: COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography) | Device ID: 1279 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen AmonMed Biotechnology Co., Ltd | Commercial: COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1763 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen AmonMed Biotechnology Co., Ltd | Commercial: 2019-nCoV IgG / IgM Detection Kit (Colloidal Gold-Based) | Device ID: 959 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd | Commercial: COVID-19 ORF1ab/N Gene PCR Detection Kit | Device ID: 442 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Xi'an Goldmag Nanobio Tech Co., Ltd | Commercial: Real-Time RT-PCR assays for the detection of SARS-CoV-2 | Device ID: 437 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Xfold Imaging | Commercial: Xfold immunoassay | Device ID: 1058 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuxi Shenrui Bio-pharmaceuticals Co. Ltd | Commercial: Covflu-SR, Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection | Device ID: 436 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd. | Commercial: SARS-CoV-2 Antigen Test Kit（Lateral Flow Assay） | Device ID: 2143 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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 |
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