| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: SARS-COV-2 R-GENE (ref 432720) | Device ID: 526 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ELITechGroup | Commercial: SARS-CoV-2 PLUS ELITe MGB® Kit | Device ID: 1862 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Lab-based, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: NZYTech | Commercial: SARS-CoV-2 One-Step RT-PCR Kit | Device ID: 1927 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd. | Commercial: SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) | Device ID: 2164 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescence Probe Method) | Device ID: 1859 | Method: Other | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Easydiagnosis Biomedicine Co., Ltd | Commercial: SARS-CoV-2 nucleic acid test kit | Device ID: 431 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Test Kit | Device ID: 1578 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: SARS-CoV-2 Nucleic Acid RT-PCR Test Kit | Device ID: 1364 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit(Multiplex PCR Fluorescent Probe Method) | Device ID: 1869 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tellgen Corporation | Commercial: SARS-CoV-2 Nucleic acid detection kit based on Cartridge Real-Time PCR platform | Device ID: 1979 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 2204 | Method: RT-PCR | Target: Nucleic acid | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 638 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TransGen Biotech Co., Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR ) | Device ID: 1750 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co., Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Gene Mutation) | Device ID: 2087 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co., Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Freeze-Dried) | Device ID: 2086 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: HANGZHOU BIOER TECHNOLOGY CO., Ltd | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence RT-PCR) | Device ID: 1287 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit | Device ID: 1658 | Method: Immunoassay | Target: Antibody, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) | Device ID: 1922 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 1921 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette ( Colloidal Gold Method) | Device ID: 1757 | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics & Instruments Co.,Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette | Device ID: 2062 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold) | Device ID: 1776 | Method: Immunoassay | Target: IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 1840 | Method: Immunoassay | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 2117 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 1584 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody Kit (CLIA) | Device ID: 1953 | Method: Immunoassay | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibody FIA Test Kit | Device ID: 2114 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) | Device ID: 1771 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA) | Device ID: 1765 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay (ELISA) | Device ID: 2216 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Neutralizing Antibody Assay (CLIA) | Device ID: 2212 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co., Ltd | Commercial: SARS-CoV-2 Neutralizing Antibodies Test Kit (Latex particle-enhanced turbidimetric immunoassay) | Device ID: 1816 | Method: Immunoassay | Target: Antibody | 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: Jiangsu Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Neutralization Antibody Test Kit (ELISA) | Device ID: 2338 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test Kit | Device ID: 2341 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2394 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 NAbs (CLIA) | Device ID: 1708 | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS., LTD. | Commercial: SARS-CoV-2 NAb Q CLIA Microparticles | Device ID: 2232 | Method: CLIA | Target: Antibody | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: AUTOBIO DIAGNOSTICS., LTD. | Commercial: SARS-CoV-2 NAb ELISA | Device ID: 2431 | Method: ELISA | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MONLAB, SL | Commercial: SARS-CoV-2 MONLABTEST | Device ID: 1961 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Foregene Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Test Kit(Colloidal Gold) | Device ID: 1872 | Method: Other | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Triplex International Biosciences Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Rapid Test Kit (Colloidal Gold) | Device ID: 1461 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Duo Test (Colloidal Gold) | Device ID: 1161 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guanxhow Fenghua Bioengineering, Co. LTD | Commercial: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | Device ID: 673 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Bioer Technology Co., Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 2059 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: BIOHIT HealthCare (Hefei) Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) | Device ID: 87 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hefei Biohit Healthcare | Commercial: SARS-CoV-2 IgM/IgG ANTIBODY TEST KIT | Device ID: 1637 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold) | Device ID: 1204 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: SARS-COV-2 IGM/IGG ANTIBODY RAPID TEST | Device ID: 1340 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan Life Origin Biotech Joint Stock Co., Ltd. | Commercial: SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography) | Device ID: 1770 | Method: Immunochromatography | Target: Antibody, IgG, IgM | 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