| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co., Ltd. | Commercial: Chemtrue® COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) | Device ID: 2312 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co., Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Diagnostic Kit (Colloidal Gold) | Device ID: 2311 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NB POSTECH | Commercial: Chexel COVID-19 IgM/IgG | Device ID: 1303 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CHIL Medical Supplies Ltd | Commercial: CHiL COVID-19 IgG/IgM Rapid Test cassette | Device ID: 1098 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: Clungene COVID-19 IgM/IgG Rapid Test Cassette | Device ID: 675 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CORMAY | Commercial: Cormay Rapid SARS-CoV-2 IgG/IgM Ab | Device ID: 1074 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hoyotek Biomedical Co.,Ltd | Commercial: Corona Virus (COVID-19) Combined (IgM/IgG/Neutralizing antibody) Rapid Test (Colloidal gold) | Device ID: 1930 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc | Commercial: Corona Virus Disease-19(COVID-19)IgG/IgM Rapid | Device ID: 1337 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV 2) Ab IgG / IgM - Nucleocapsid (N protein) | Device ID: 1936 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: RayBiotech | Commercial: Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) | Device ID: 337 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV-2) Neutralizing Antibodies | Device ID: 1933 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Other | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd | Commercial: Coronavirus COVID-19 IgM/IgG Test Kit | Device ID: 1440 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Wesail Biotech Co., Ltd | Commercial: Coronavirus COVID-19 lgM/IgG Test Kit (colloidal) | Device ID: 1428 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co. Ltd. | Commercial: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Device ID: 2050 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check - COVID-19 IgG/IgM Test | Device ID: 1086 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Tauschen Int. Ltd (Tauschen Groups) | Commercial: COVID - 19 RAPID TEST KIT / Antibody IgG & IgM Test Kit | Device ID: 620 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ | Commercial: Covid PRESTO Test rapide COVID-19 IgG/IgM | Device ID: 964 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anhui Deep Blue Medical Technology Co., Ltd | Commercial: COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit | Device ID: 510 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Labnovation Technologies Inc | Commercial: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit | Device ID: 577 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo | Device ID: 1385 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test | Device ID: 1697 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2436 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: New Gene (Hangzhou) Bioengineering Co., Ltd. | Commercial: COVID-19 Antibody Detection Kit | Device ID: 2306 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | 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: Surge Medical Inc. | Commercial: COVID-19 IgG/IgM Antibody Assay Kit(Colloidal Gold Method) | Device ID: 1932 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co., Ltd | Commercial: Covid-19 IgG/IgM Antibody Rapid Test Kit | Device ID: 634 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NTBio Diagnostics Inc | Commercial: COVID-19 IgG/IgM Antibody Test Cassette | Device ID: 661 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Testsea Biotechnology Co., Ltd | Commercial: COVID-19 IgG/IgM Antibody Test(Colloidal Gold) | Device ID: 1632 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio-Products Co., Ltd | Commercial: COVID-19 IgG/IgM Combo Rapid Test Device | Device ID: 264 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hunan Lituo Biotechnology Co., Ltd | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 220 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 1155 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 1186 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co.,Ltd. | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 646 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biozek Medical | Commercial: Covid-19 IgG/IgM Rapid Test | Device ID: 1012 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | 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: Monocent, Inc | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1321 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test | Device ID: 1381 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG/IgM Rapid Test (cassette) | Device ID: 1389 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spring Healthcare Services AG | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Device ID: 618 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG/IgM Rapid Test (For Reader) | Device ID: 1479 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: COVID-19 IgG/IgM Rapid Test (For Reader) | Device ID: 1677 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG/IgM Rapid Test (Strip) | Device ID: 1394 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2433 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) | Device ID: 2439 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Biozek Medical | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 464 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 465 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Syrona Limited | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 619 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1377 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOLAN HEALTH, S.L. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1829 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Sejoy Electronics&Instruments Co.,LTD. | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1970 | Method: Immunoassay | 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