| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | Device ID: 2183 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Getein Biotech Inc. | Commercial: One Step Test for SARS-CoV-2 Total Antibody /Neutralizing Antibody (Colloidal Gold) | Device ID: 2589 | Method: Immunoassay | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diagnostic Automation/Cortez Diagnostics Inc. | Commercial: OneStep COVID-19 Antigen RapiCard InstaTest | Device ID: 1195 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 Ag Rapid Test | Device ID: 1581 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 IgG/IgM | Device ID: 535 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CTK Biotech Inc. | Commercial: OnSite COVID-19 IgG/IgM Rapid Test | Device ID: 902 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OPTI Medical Systems | Commercial: OPTI SARS-CoV-2 Total Antibody Test Kit | Device ID: 1422 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Tezted | Commercial: Oy SARSPLEX | Device ID: 811 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Diamond - OZO SARS-CoV-2 IgM + IgG Method | Device ID: 474 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Gold - OZO SARS-CoV-2 IgG Method | Device ID: 475 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OZO Life | Commercial: OZO Silver - OZO SARS-CoV-2 IgM Method | Device ID: 476 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 IgM/IgG | Device ID: 320 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: PRIME4DIA Co. Ltd. | Commercial: P4DETECT COVID-19 SAg | Device ID: 319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest Coronavirus Ag | Device ID: 1270 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pantest SA | Commercial: Pantest de Coronavirus IgM/IgG 2019-n-CoV | Device ID: 1003 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Ag Lateral Flow Test Device | Device ID: 2320 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Fluorescence Immunoassay Kit | Device ID: 2422 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Antigen Lateral Flow Test Device | Device ID: 2408 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Mylab Discovery Solutions Pvt. Ltd. | Commercial: PathoCatch COVID-19 Neutralizing Antibody Lateral Flow Test Kit | Device ID: 2425 | Method: Immunoassay | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 Ag Rapid FIA | Device ID: 308 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PCL Inc. | Commercial: PCL COVID19 IgG/IgM Rapid Gold | Device ID: 307 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Canary Global Inc. | Commercial: Pelican COVID-19 Ultra-Rapid Mobile Test | Device ID: 2283 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Device ID: 1264 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zephyr Biomedicals-Tulip Diagnostics | Commercial: PerkinElmer COVID-19 Antigen Test (NS,NP) | Device ID: 2687 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Viola Diagnostics Systems-Tulip Diagnostics | Commercial: PerkinElmer® COVID-19 Antigen Test | Device ID: 3147 | Method: Immunoassay | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Bio-Rad Laboratories Inc. | Commercial: Platelia SARS-CoV-2 Total Ab Assay | Device ID: 756 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: PRIMA Lab SA | Commercial: PRIMA COVID-19 IgG/IgM Rapid Test (For Professional Use) | Device ID: 318 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Synbiotik Biotechnology | Commercial: Q-Check Rapid Lateral Flow Assay for SARS-CoV-2 Antigen Detection | Device ID: 2884 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Attomarker Ltd. | Commercial: Quantitative Immuno-kinetic assay for Covid-19 IgG+IgM+IgA for a multiantigen panel with CRP | Device ID: 44 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Diacarta Inc. | Commercial: Quantivirus Anti-SARS-CoV-2 IgG Test | Device ID: 3035 | Method: Immunoassay | Target: IgG | Format: Automated | Go to details |
| CE Marking: No | Manufacturer: Denka Seiken Co. Ltd. | Commercial: QuickNavi-COVID19 | Device ID: 780 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc. | Commercial: QuickProfile 2019-nCoV IgG/IgM Combo Test Card | Device ID: 268 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: LumiQuick Diagnostics Inc. | Commercial: QuickProfile COVID-19 Antigen Test | Device ID: 1267 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tianjin New Bay Bioresearch C | Commercial: Quik Pac II COVID-19 IgG & IgM Test | Device ID: 1631 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Response Biomedical Corp. | Commercial: RAMP COVID-19 Antigen Test | Device ID: 2095 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genes2me Private LTD | Commercial: RapiCov Rapid Antigen Test Kit for COVID‐19 | Device ID: 4072 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: MP Biomedicals | Commercial: Rapid 2019-nCoV IgG/IgM Combo Test | Device ID: 1126 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd. | Commercial: Rapid 2019-nCoV IgG/IgM Combo Test Card | Device ID: 439 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Nirmidas Biotech Inc. | Commercial: Rapid COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | Device ID: 297 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc. | Commercial: Rapid COVID-19 Antigen Qualitative Test Kit | Device ID: 1182 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Healgen Scientific | Commercial: Rapid COVID-19 Antigen Test | Device ID: 1735 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold )/ Saliva | Device ID: 2604 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Anbio (Xiamen) Biotechnology Co. Ltd. | Commercial: Rapid COVID-19 Antigen Test (Colloidal Gold) | Device ID: 1822 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Megna Health Inc. | Commercial: Rapid COVID-19 IgM/IgG Combo Test Kit (Antibody) | Device ID: 1063 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: Rapid Immunoassay Test Cassette | Device ID: 466 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 Antigen Rapid Test Cassette (Oral Fluid) | Device ID: 1684 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: BTNX Inc. | Commercial: Rapid Response COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Device ID: 110 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antibody (IgM/IgG) | Device ID: 229 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: InTec Products Inc. | Commercial: Rapid SARS-CoV-2 Antibody Test | Device ID: 228 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Boson Biotech Co. Ltd. | Commercial: Rapid SARS-CoV-2 Antigen Test Card | Device ID: 2264 | Method: Immunoassay | Target: Antigen | Format: Manual, 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