| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd | Commercial: SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (Fluorescence Immunoassay) | Device ID: 1227 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd | Commercial: SARS-CoV-2 IgG assay | Device ID: 1076 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | Commercial: SARS-CoV-2 IgG/IgM (GICA) | Device ID: 1712 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beroni Group | Commercial: SARS-CoV-2 IgG/igM Antibody Detection Kit | Device ID: 697 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Goldsite Diagnostics Inc | Commercial: SARS-CoV-2 IgG/IgM Kit (manual) | Device ID: 192 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | 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: BN Santé | Commercial: SARS-CoV-2 IgG/IgM Rapid Test | Device ID: 2194 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan NanoDiagnosis for Health Biotechnology Co., Ltd | Commercial: SARS-CoV-2 IgG/IgM Rapid Test Cassette (Colloidal Gold Method) | Device ID: 1755 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd | Commercial: SARS-CoV-2 IgG/IgM Rapid Test Device | Device ID: 985 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co., Ltd | Commercial: SARS-CoV-2 IgG/IgM Rapid Test (CE-IVD) | Device ID: 828 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 IgG/M Antibody Assay kit by Colloidal Gold Method | Device ID: 1661 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: SARS-CoV-2 IgM | Device ID: 1054 | Method: Immunoassay | Target: Antibody, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Mokobio Biotechnology R&D Center | Commercial: SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay | Device ID: 285 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd | Commercial: SARS-CoV-2 IgM (CLIA) | Device ID: 988 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: SARS-CoV-2 IgM Ab Rapid Test | Device ID: 391 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc | Commercial: SARS-CoV-2 IgM and IgG Antibody Assay Kit | Device ID: 637 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: GenaBio Diagnostics Inc. | Commercial: SARS-CoV-2 IgM/IgG (GICA) Test | Device ID: 1576 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Ab Rapid Test | Device ID: 390 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Turklab | Commercial: SARS-CoV-2 IgM/IgG Ab Test | Device ID: 1690 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd | Commercial: SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) | Device ID: 871 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | 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: 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: 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: 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: 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: 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: 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: MONLAB, SL | Commercial: SARS-CoV-2 MONLABTEST | Device ID: 1961 | Method: Immunoassay | Target: Antigen | Format: Manual | 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test | Device ID: 1604 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SARS-CoV-2 Rapid Antigen Test Cassette | Device ID: 2297 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Medomics Medical Technologies | Commercial: SARS-CoV-2 rapid combined IgM/IgG antibody test kit | Device ID: 500 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-CoV-2 Rapid TesIgM/IgG | Device ID: 485 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pharmact (Berlin) | Commercial: SARS-COV-2 Rapid Test | Device ID: 501 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2395 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd. | Commercial: SARS-CoV-2 S-RBD Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2403 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2400 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd. | Commercial: SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2404 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd | Commercial: SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 1178 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd | Commercial: SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) | Device ID: 1228 | Method: Immunoassay | Target: Antigen | Format: | 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