| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Autobio Diagnostics Co., Ltd | Commercial: SARS-CoV-2 IgG II CLIA Microparticles | Device ID: 919 | Method: CLIA | Target: Antibody, IgG | Format: Automated, 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: Vector-Best | Commercial: SARS-CoV-2-IgG-EIA-BEST | Device ID: 1463 | Method: Immunoassay | Target: Antibody, IgG | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Orient Gene Biotech Co ltd | Commercial: Sars_Cov_2 NEUTRALIZING ANTIBODY Rapid Test Cassette GCCOV(NAb)-402b | Device ID: 2497 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: InBios International | Commercial: SCoV-2 Detect IgG ELISA | Device ID: 1409 | Method: ELISA | Target: Antibody, IgG | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) | Device ID: 1071 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody) | Device ID: 2028 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgG | Device ID: 1104 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgG | Device ID: 1149 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: bioMérieux SA | Commercial: VIDAS SARS-COV-2 IgG | Device ID: 881 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: VIROTECH SARS-CoV-2 IgG | Device ID: 880 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VIROTECH Diagnostics GmbH | Commercial: VIROTECH SARS-CoV-2 IgG ELISA | Device ID: 1164 | Method: ELISA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co., Ltd | Commercial: Wondof SARS-CoV-2 IgG Antibody Test (Lateral Flow Method) | Device ID: 1212 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Dewei Medical Equipment Co., LTD. | Commercial: Covid-19 (2019-nCoV) Antigen Rapid Test Cassette | Device ID: 2279 | Method: Immunochromatography | Target: Antibody, IgG, Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mikrogen Diagnostik | Commercial: recomWell SARS-CoV-2 IgG | Device ID: 1629 | Method: Immunoassay | Target: Antibody, IgG, IgA | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co., Ltd | Commercial: (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold) | Device ID: 1355 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Natejah | Commercial: (COVID-19) IgG/IgM Rapid Test | Device ID: 1019 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: JinHuan Medical Instrument Co., Ltd | Commercial: (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Device ID: 575 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lansion Biotechnology Co., Ltd. | Commercial: (COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) | Device ID: 1649 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shandong ThinkLab Biotechnology Co., Ltd | Commercial: 09-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) | Device ID: 945 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd | Commercial: 2019 nCOV IgG/IgM Rapid Test | Device ID: 152 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Edinburgh Genetics Limited | Commercial: 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) | Device ID: 156 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co., Ltd. | Commercial: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) | Device ID: 227 | Method: Immunoassay | Target: Antibody, IgG, IgM | 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: Yes | Manufacturer: Biolidics | Commercial: 2019-nCoV IgG/IgM Antibody Detection Kit | Device ID: 497 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV IgG/IgM Antibody Rapid Test Kit | Device ID: 960 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd | Commercial: 2019-nCoV IgG/IgM Device | Device ID: 1048 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Clongene Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 568 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1070 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIOMAXIMA S.A. | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 88 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co., Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 208 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 1390 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 1696 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acro Biotech Inc | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2434 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CITEST DIAGNOSTICS INC | Commercial: 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 2438 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vazyme | Commercial: 2019-nCoV IgG/IgM Rapid Testing Kit | Device ID: 766 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: U2USystems (India) Pvt. Ltd | Commercial: 2019-ncoV IgG/IgM Test | Device ID: 489 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prometheus Bio Inc | Commercial: 2019-nCOV IgG/IgM Test Cassette (Whole blood/Serum/Plasma) | Device ID: 868 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd | Commercial: 2019-nCOV IgG/LgM Rapid Test Device | Device ID: 570 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Bioteke Taizhou Biotechnology Co., Ltd | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 1488 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific, Inc. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method) | Device ID: 1807 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd | Commercial: 2019-nCoV IgMIgG Antibody Test Kit (Nephelometry immunoassay method) Automatic ImmunoAssay System - HP-AFS/1 | Device ID: 1095 | Method: Nephelometry | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shijiazhuang Hipro Biotechnology Co.,Ltd | Commercial: 2019-nCoV IgMIgG Antibody Test Kit POCT Immunoassay System - HP-083/4 | Device ID: 1094 | Method: Nephelometry | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Neo Nostics (Suzhou) Bioingeneering Co. LTD | Commercial: 2019-nCoV(COVID-19) IgG&IgM Rapid Test Kit | Device ID: 1022 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Beier Bioengineering Co., Ltd | Commercial: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P) | Device ID: 1359 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Akralab | Commercial: 2019nCoV IgG/IgM Rapid test Device | Device ID: 1002 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2 (ICA) | Device ID: 1680 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD | Commercial: A Rapid IgM-IgG Combined Antibody Test Kit for SARS-Cov-2-(ICA) | Device ID: 1645 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: A&B Professional | Commercial: A&B RAPID TEST COVID-19 IGG/IGM CASSETTA | Device ID: 1004 | 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