| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: Beijing Diagreat Biotechnologies Co., Ltd | Commercial: 2019-nCoV Antigen Rapid Test Kit (colloidal gold assay) | Device ID: 1283 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co., Ltd | Commercial: 2019-nCoV Antigen Rapid Test (Colloidal Gold) | Device ID: 1273 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Prestige Diagnostics | Commercial: 2019-nCoV Antigen Device | Device ID: 1202 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | 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: INNOVITA (Tangshan) Biological Technology Co., Ltd. | Commercial: 2019-nCoV Ag Test (Latex Chromatography Assay) | Device ID: 1994 | Method: Immunoassay | 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) (Oropharyngeal swab) | Device ID: 2509 | Method: Immunoassay | 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) (Nasopharyngeal Swab) | Device ID: 2504 | Method: Immunoassay | Target: Antigen | 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: Hangzhou Singclean Medical Products Co., Ltd | Commercial: 2019-nCoV Ab Test (Colloidal Gold) | Device ID: 1000 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd | Commercial: 2019- nCoV Antigen Rapid Test | Device ID: 1873 | Method: Immunoassay | Target: Antigen | Format: 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: 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: 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: 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: 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: 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: Jiangsu Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Total Antibody Test Kit (ELISA) | Device ID: 2337 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Neutralization Antibody Test Kit (ELISA) | Device ID: 2338 | Method: ELISA | Target: Antibody | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: R-Biopharm AG | Commercial: RIDA®GENE Flu & SARS-CoV-2 | Device ID: 1851 | Method: RT-PCR | Target: Nucleic acid | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Plexense, Inc. | Commercial: ACCEL ELISA COVID-19 kit | Device ID: 2005 | Method: ELISA | Target: Antibody, IgG, IgM, IgA | Format: Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: LLC EMG- Evotech Mirai Genomics | Commercial: SmartAmp SARS-CoV-2 RNA detection test kit | Device ID: 1951 | Method: LAMP | Target: Nucleic acid | Format: Manual, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: VITASSAY HEALTHCARE SL | Commercial: Vitassay SARS-CoV-2 | Device ID: 2268 | Method: Immunochromatography | Target: Antigen | Format: Manual, Other | Go to details |
| CE Marking: Yes | Manufacturer: Genomtec S.A. | Commercial: SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit | Device ID: 2446 | Method: LAMP | Target: | Format: Manual, Other | Go to details |
| CE Marking: Yes | Manufacturer: Tody Laboratories Int. | Commercial: Coronavirus (SARS-CoV-2) Neutralizing Antibodies | Device ID: 1933 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Other | Go to details |
| CE Marking: Yes | Manufacturer: OPERON, S.A. | Commercial: SIMPLE IgA/IgM/IgG SARS-CoV-2 | Device ID: 2171 | Method: Immunochromatography | Target: Antibody, IgG, IgM, IgA | Format: Manual, Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd | Commercial: Saliva Orawell Covid_19 Ag | Device ID: 2490 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: OPERON, S.A. | Commercial: SIMPLE/STICK Ag SARS-CoV-2 | Device ID: 2170 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Other, Semi-automated | 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: Jiangsu Well Biotech Co. Ltd | Commercial: OraWell COVID-19 NEUTRALIZING ANTIBODY Rapid Test Device - CO_04 (Check vaccination coverage) | Device ID: 2496 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Well Biotech Co. Ltd | Commercial: OraWell COVID-19 Ag.Rapid Saliva test DEVICE, CO-07(One Step) | Device ID: 2495 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Other, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Hongyu Medical Commodity Co.,Ltd | Commercial: SARS-CoV-2 Ag Rapid Test Kit | Device ID: 2309 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Zhejiang Hongyu Medical Commodity Co.,Ltd | Commercial: COVID-19 Neutralizing Antibody Multiple Detection Kit | Device ID: 2310 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual, Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Zekmed | Commercial: Zekmed antigen rapid test cassette (colloidal gold) | Device ID: 1914 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Vaxxitest 2019-nCoV Neutralizing Antibody Test | Device ID: 2521 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unibioscience AS | Commercial: Unibioscience Covid-19 Rapid Antigen Saliva Test | Device ID: 2522 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unioninvest Ltd. | Commercial: Unibioscience Covid-19 Nasopharynx Antigen Test | Device ID: 2523 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Technogenetics s.r.l. | Commercial: TGS Velox Ag COVID-19 POCT SALIVA (25 test) | Device ID: 2274 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PREMIER MEDICAL CORPORATION PRIVATE LIMITED | Commercial: SURE STATUS COVID-19 ANTIGEN CARD TEST | Device ID: 2299 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Sienna COVID-19 Antigen Rapid Test Cassette | Device ID: 2127 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics Saliva Antigen Rapid Test Kit | Device ID: 2539 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | Device ID: 2540 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics Dual Immunity Rapid Test Kit (anti-Spike RBD IgG and anti-Nucleocapsid Protein Antibodies) | Device ID: 2541 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | Device ID: 2544 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity IgG/IgM Rapid Test Kit | Device ID: 2542 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 IgG/IgM Rapid Test Kit | Device ID: 2543 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) IgM/IgG Antibody Assay Kit by Colloidal Gold Method | Device ID: 1918 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Maccura Biotechnology Co., Ltd | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method | Device ID: 1917 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Vazyme Medical Technology Co., Ltd | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) | Device ID: 1849 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Mole Bioscience CO., LTD. | Commercial: SARS-CoV-2 Total Antibody Rapid Test Kit | Device ID: 2339 | Method: Immunochromatography | Target: Antibody | 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