| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 212 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genitech NSAN Pharmaceutical Pvt. Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 563 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 677 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai International Holding Corp. GmbH(Europe) (DE) | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 987 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Assure Tech. (Hangzhou) Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 664 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Azure Biotech Inc | Commercial: COVID-19 IgG/IgM Rapid Test Device | Device ID: 1912 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Plasma/Serum) | Device ID: 1035 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Dipstick | Device ID: 1382 | 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 Dipstick | Device ID: 1694 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Kit | Device ID: 651 | 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 Test Cassette | Device ID: 1475 | 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 Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 857 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2393 | 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 Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2416 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co., Ltd | Commercial: Covid-19 IgG/IgM test kit (Colloidal Gold Method) | Device ID: 1001 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Core Technology Co., Ltd | Commercial: COVID-19 IgM/IgG Ab Test | Device ID: 132 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pro-med （Beijing） Technology Co., Ltd. | Commercial: COVID-19 IgM/IgG Antibody Rapid Detection Kit（Colloidal Gold） | Device ID: 2486 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tianjin Era Biology Technology Co., Ltd | Commercial: COVID-19 IgM/IgG Lateral Flow Assay | Device ID: 624 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BioMedomics, Inc | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 90 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: WHPM | Commercial: COVID-19 IgM/IgG Rapid Test | Device ID: 1630 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Well Biotech | Commercial: COVID-19 IgM/IgG Rapid Test (Colloidal Gold) | Device ID: 1027 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: MedicalSystem Biotechnology Co., Ltd | Commercial: COVID-19 IgM/IgG Rapid Test Cassette | Device ID: 276 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ring Biotechnology Co., Ltd | Commercial: COVID-19 IgM/IgG Rapid Test Kit | Device ID: 603 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Dakewe Bio-engineering Co., Ltd. | Commercial: COVID-19 IgM/IgG Rapid Test Kit | Device ID: 1998 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co., Ltd. | Commercial: COVID-19 lgM/lgG Antibody Diagnostic Kit(Colloidal Gold) | Device ID: 2527 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Innovation Biotech(Beijing)Co.ltd | Commercial: COVID-19 Neutralizing Antibody Rapid Test Device | Device ID: 2287 | Method: | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte., Ltd | Commercial: COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401) | Device ID: 870 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Accuster Technologies Pvt Ltd | Commercial: COVID-19 RAPID IgG/IgM test kit | Device ID: 762 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Willi Fox GmbH | Commercial: COVID-19 Test IgM/ IgG | Device ID: 983 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VEDALAB | Commercial: COVID-19-CHECK-1 test | Device ID: 1069 | Method: Chromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth Nano Fluorescence Immunochromatography) | Device ID: 28 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: JOYSBIO (Tianjin) Biotechnology Co., Ltd | Commercial: COVID-9 IgG/IgM Rapid Test Kit (Colloidal Gold) | Device ID: 933 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AAZ-LMB | Commercial: COVID-PRESTO | Device ID: 1835 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Multi-G bvba | Commercial: Covid19Check-MG | Device ID: 2262 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co., Ltd | Commercial: COVIDTECH One Step SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 1452 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eternal Materials Co., Ltd | Commercial: COVIDual COVID-19 IgM/IgG Rapid Test | Device ID: 1066 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Bohui Innovation Biotechnology Co., Ltd. | Commercial: COVlD-19 IgM/IgG Antibodies Rapid Test(Colloidal GoId Method) | Device ID: 2055 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Dablood pharmaceutical | Commercial: DABLOOD COVID-19 IgM/IgG Rapid Antibody Test | Device ID: 1634 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Genesprint Group Limited | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2 | Device ID: 1609 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: Novatech | Commercial: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 | Device ID: 1582 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd. | Commercial: Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold) | Device ID: 2178 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhuhai Livzon Diagnostics Inc | Commercial: Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) | Device ID: 879 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: Diaquick Covid-19 IgG/IgM | Device ID: 1055 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DIALAB GmbH | Commercial: DIAQUICK COVID-19 IgG/IgM Cassette Rapid Test | Device ID: 986 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: DyonCovid19 - SARS-CoV-2 IgM/IgG Antibody Rapid Test Device. | Device ID: 991 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined | Device ID: 662 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte., Ltd | Commercial: EDR COVID 19 Rapid Test Kit (IgM/IgG) | Device ID: 351 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: fago medikal san. tic. ltd. şti. | Commercial: FAMEX SARS-CoV-2 RAPID ANTIBODY TEST | Device ID: 2175 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Finecare SARS-CoV-2 IgM/IgG Test | Device ID: 1211 | 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