| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test | Device ID: 463 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prognosis Biotech | Commercial: Home Test COVID-19 Ag | Device ID: 3615 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: No | Manufacturer: Predigen Inc. | Commercial: HR-PreV | Device ID: 315 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgG/IgM Rapid Test | Device ID: 248 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: KRISHGEN BioSystems | Commercial: Human Anti-SARS-CoV-2 (Covid-19) IgM Rapid Test | Device ID: 247 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Humasis Co. Ltd. | Commercial: Humasis COVID-19/Flu Ag Combo Test | Device ID: 1262 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma COVID-19/Flu Ag Combo | Device ID: 1448 | Method: Immunoassay | Target: Antigen | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Ichroma COVID-19 Ab, IgM/IgG | Device ID: 837 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: Ichroma COVID-19, viral Antigen | Device ID: 107 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 nAb | Device ID: 2398 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Boditech Med Inc. | Commercial: ichroma™ COVID-19 SP/NP IgG | Device ID: 2784 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innovative Diagnostics | Commercial: iD Rapid® COVID-19 Antigen | Device ID: 1728 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Innovative Diagnostics | Commercial: ID Screen® SARS-CoV-2 Double Antigen Multi-species | Device ID: 1727 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-2019-nCoV Antigen | Device ID: 1169 | Method: Immunoassay | Target: Antigen | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-2019-nCoV IgA | Device ID: 1081 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-2019-nCoV NAb | Device ID: 1477 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-SARS-CoV-2 IgG | Device ID: 1079 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH Co. Ltd. | Commercial: iFlash-SARS-CoV-2 IgM | Device ID: 1080 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: OSANG Healthcare Co. Ltd. | Commercial: Immuno-on COVID-19 IgG Test | Device ID: 3105 | Method: Immunoassay | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Anji Saianfu Biotech Co. Ltd. | Commercial: Immunobio SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non invasive) | Device ID: 1845 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: PHASE Scientific International Limited | Commercial: INDICAID COVID-19 Rapid Antigen Self-Test | Device ID: 3150 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Nantong Diagnos Biotechnology Co. Ltd. | Commercial: Influenza A+B Antigen Test Kit (Colloidal Gold) | Device ID: 1301 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: NewScen Coast Bio-Pharmaceutical Co. Ltd. (NewScen) | Commercial: Influenza Antigen A/B Rapid Test | Device ID: 2846 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Eurofins | Commercial: INGEZIM Covid 19 CROM | Device ID: 1682 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: B-bio Co. Ltd. | Commercial: INNOGEN-B™ COVID-19 IgM/IgG Rapid test | Device ID: 1615 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Innovation Scientific Pty Ltd. | Commercial: InnoScreenTM COVID-19 Antigen Rapid Test Device | Device ID: 2566 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Innova Medical Group Inc. | Commercial: Innova SARS CoV-2 Antigen Rapid Qualitative Test | Device ID: 1801 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Confirm Bioscience | Commercial: Instant COVID-19 “Coronavirus” Test | Device ID: 131 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Vitrosens Biotechnology Co. Ltd. | Commercial: Instant SARS-CoV-2 Rapid Ag Test | Device ID: 1444 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view PLUS COVID-19 Test | Device ID: 958 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Alfa Scientific Designs Inc. | Commercial: Instant-view® PLUS COVID-19 Antigen Test | Device ID: 1678 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Suzhou Soochow University Saier Immuno Biotech Co. Ltd. | Commercial: InstantSure Covid-19 Ag CARD | Device ID: 3015 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Chongqing iSIA BIO-Technology Co. Ltd. | Commercial: iSIA | Device ID: 2056 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Abionic SA | Commercial: IVD CAPSULE COVID-19-NP | Device ID: 2975 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Abionic SA | Commercial: IVD CAPSULE COVID-19-SS | Device ID: 2993 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Jinwofu Bioengineering Technology Co. Ltd. | Commercial: Jinwofu® Novel Coronavirus (SARS-CoV-2) Antigen-Rapid-Test | Device ID: 1725 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 Antigen Detection Rapid Test | Device ID: 244 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Kephera Diagnostics | Commercial: KDx COVID-19 IgG/IgM Rapid Detection Test Kit | Device ID: 242 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 1284 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (FIA) | Device ID: 70 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) | Device ID: 1285 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 IgG/IgM antibody Rapid Test Kit (Colloidal Gold) | Device ID: 71 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc. | Commercial: Kewei COVID-19 total antibody rapid test | Device ID: 1112 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Asan Pharmaceutical Co. Ltd. | Commercial: KNAX-SMART SARS-CoV-2 IgM/IgG | Device ID: 2537 | Method: Immunoassay | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Quark Biotechnology Co. Ltd. | Commercial: Kwork Covid-19 Ag Rapid Test Device(Saliva/Sputum/Feces) | Device ID: 1322 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time 2019-nCoV IgG/IgM Rapid Test | Device ID: 1168 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BMT Diagnostics | Commercial: Lab-On-Time COVID-19 Antigen Rapid Test Device (Integrated Throat Swab) | Device ID: 1605 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Leadgene Biomedical Inc. | Commercial: Leadgene SARS/SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 257 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Leadgene Biomedical Inc. | Commercial: Leadgene SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit | Device ID: 258 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: LIAISON SARS-CoV-2 S1/S2 IgG | Device ID: 911 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated | 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