| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondof SARS-CoV-2 IgM Antibody Test | Device ID: 1306 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: Wondof SARS-CoV-2 IgM Antibody Test (Lateral Flow Method) | Device ID: 1213 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Xfold Imaging | Commercial: Xfold immunoassay | Device ID: 1058 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Zhenrui Biotechnology Co. Ltd. | Commercial: Zhenrui ®COVID-19 Antigen Test Cassette | Device ID: 1574 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Zugotech Labs Ltd. | Commercial: Zugotech COVID-19 IgM/IgG Rapid Test | Device ID: 458 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | Device ID: 3999 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Bioantibody Biotechnology Co. Ltd. | Commercial: (COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography) | Device ID: 2706 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Pierenkemper GmbH | Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 | Device ID: 2672 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Pierenkemper GmbH | Commercial: (SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19 / Saliva | Device ID: 2197 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: 2019- nCoV and Flu A/B Antigen Combo Rapid Test Kit (Colloid Gold Immunoassay) | Device ID: 1874 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Reach Diagnostic (Wuhan) Biotech Co. Ltd. | Commercial: 2019-nCoV Ag & FLU A/B ComboRapid Test | Device ID: 4086 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag & Influenza A/B Rapid Co-DetectionKit (Immuno-Chromatography) | Device ID: 1342 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag & Influenza AB Ag RapidCo-Detection Kit (Immuno-Chromatography) | Device ID: 1323 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Longsee Biomedical Co. Ltd. | Commercial: 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) | Device ID: 1216 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Huachenyang (Shenzhen) Technology Co. Ltd. | Commercial: 2019-nCoV Ag Rapid Test Kit - REF: CY-F006-AG25 | Device ID: 1748 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Antigen Device | Device ID: 1203 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Antigen Device (Anterior Nasal Swab) | Device ID: 2570 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Antigen Device (Anterior Nasal Swab) | Device ID: 2605 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCOV Antigen Rapid Test | Device ID: 5766 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Superbio Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) | Device ID: 3086 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: 2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | Device ID: 1790 | Method: Immunochromatography | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: 2019-nCoV Antigen Test (Lateral Flow Method) | Device ID: 3991 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Wondfo Biotech Co. Ltd. | Commercial: 2019-nCoV Antigen Test (Lateral Flow Method) - Nasal and Saliva | Device ID: 3992 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing M&D Biotechnology Co. Ltd. | Commercial: 2019-nCoV Antigen Test Kit | Device ID: 2150 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) | Device ID: 1747 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Antigen Test Kit (colloidal gold method) (for self-testing) | Device ID: 4088 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Lepu Medical Technology Co. Ltd. | Commercial: 2019-nCoV antigen, Influenza A virus antigen, Influenza B virus antigen detection kit (colloidal gold immunochromatography) | Device ID: 3078 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | 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: Biobase Biodustry（Shandong） Co. Ltd. | Commercial: 2019-nCoV IgM/IgG Antibody Test Kit（Colloidal Gold） | Device ID: 2895 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: AMS UK (NI) Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2225 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics UK Ltd. | Commercial: 2019-nCoV Neutralising Antibody | Device ID: 2227 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: 2019-nCoV Neutralizing Antibody Assay (Colloidal Gold) | Device ID: 2220 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: INNOVITA (Tangshan) Biological Technology Co. Ltd. | Commercial: 2019-nCoV Neutralizing Antibody Test (Quantum Dot Immunofluorescence Chromatography) | Device ID: 2531 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangdong Hecin Scientific Inc. | Commercial: 2019-nCoV Neutralizing Antibody Test Kit (Fluorescent immunochromatography) | Device ID: 1812 | Method: Immunochromatography | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: 2019-nCoV Rapid Antigen Test | Device ID: 2468 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Guangzhou Decheng Biotechnology Co. Ltd. | Commercial: 2019-nCoV Saliva Ag EASY TEST | Device ID: 2498 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abingdon Health Plc | Commercial: AbC-19 Semi-Q Rapid Test | Device ID: 2879 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 Ag Rapid | Device ID: 1981 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Absology Co. Ltd. | Commercial: Absoludy COVID-19 NAb Rapid | Device ID: 1985 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 Antigen Cassette (Nasal Swab) | Device ID: 2578 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 Antigen Cassette (Saliva) | Device ID: 2580 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell COVID-19 IgG/IgM Cassette | Device ID: 14 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: Accu-Tell SARS-CoV-2 Ag Cassette | Device ID: 2579 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AccuBioTech Co. Ltd. | Commercial: ACCU-TELL® SARS-CoV-2 Neutralizing Antibody Cassette | Device ID: 2581 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Actim Oy | Commercial: Actim SARS-CoV-2 | Device ID: 2245 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Actim Oy | Commercial: Actim SARS-CoV-2 + Actim Influenza A&B | Device ID: 2969 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acura Kliniken Baden-Baden GmbH | Commercial: Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit | Device ID: 2459 | Method: Immunochromatography | Target: Antibody, Antigen | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: ADTech Co. Ltd. | Commercial: ADTech COVID-19 Ag RAPID KIT | Device ID: 2736 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Zhongsheng Langjie Biotechnology Co. Ltd. | Commercial: AgiAccu COVID-19 Antigen Test Cassette | Device ID: 2510 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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