| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: FENG CHUN YUAN MEDICAL EQUIPMENT(SHENZHEN) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Detection Kit | Device ID: 2598 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody FIA Test Kit | Device ID: 2114 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Quantitative Test Kit (Immunofluorescence Method) | Device ID: 3996 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 2117 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Acon Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test | Device ID: 2603 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Biotest Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Combo) | Device ID: 4114 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit | Device ID: 3988 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold Chromatographic Immunoassay) | Device ID: 2620 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Biosino Bio-Technology and Science Inc. | Commercial: SARS-CoV-2 Neutralizing antibody Test KIT (Colloidal gold) | Device ID: 2865 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (Immunofluorescence Method) | Device ID: 3994 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Weihai Dishang Medical Technology Co. Ltd. | Commercial: SARS-CoV-2 Neutralizing Antibody Test Kit (LFIA) | Device ID: 2803 | Method: Immunochromatography | Target: Antibody | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Zheda Dixun Biological Gene Engineering Co. Ltd. | Commercial: SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Test Cassette (Swab) | Device ID: 2942 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) | Device ID: 2097 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) | Device ID: 2366 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) (Self-testing) | Device ID: 3108 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou AllTest Biotech Co. Ltd. | Commercial: SARS-COV-2 rapid antigen test (Swab) | Device ID: 1946 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test 2.0 | Device ID: 25546 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test 2.0 Nasal | Device ID: 5839 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HA TECH PTY Ltd. | Commercial: SARS-CoV-2 Rapid Antigen Test Kit (RAT-01) | Device ID: 4158 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: HA TECH PTY Ltd. | Commercial: SARS-CoV-2 Rapid Antigen Test Kit (RAT-01) | Device ID: 4160 | Method: Immunochromatography | Target: Antibody | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Rapid Antigen Test Nasal | Device ID: 2228 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Hunan Yonghe-Sun Biotechnology Co. Ltd. | Commercial: SARS-COV-2 specific antibody test kit (Immunochromatography) | Device ID: 221 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 Total Antibody & Neutralizing Antibody Test Kit | Device ID: 3997 | Method: Immunochromatography | Target: Antibody | Format: 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 |
| CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method) | Device ID: 2585 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) | Device ID: 3920 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal | Device ID: 2907 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co. Ltd. | Commercial: SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Nasal (self-test) | Device ID: 2658 | Method: Immunochromatography | Target: Antigen | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2&Flu A& Flu B Ag Rapid Test | Device ID: 2119 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co. Ltd. | Commercial: SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab) | Device ID: 1789 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2/ Flu A/ Flu Ag FIA Test | Device ID: 2120 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Qingdao Hightop Biotech Co. Ltd. | Commercial: SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test | Device ID: 2754 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Kisshealth Biotechnology Co. Ltd. | Commercial: SARS-CoV-2/Human Influenza Virus A&B（Flu A&B）Antigen Test Kit(Colloidal Gold) | Device ID: 1814 | Method: Immunochromatography | Target: Antigen | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Joinstar Biomedical Technology Co. Ltd. | Commercial: SARS-COV-2/Influenza A&B Rapid Antigen Test | Device ID: 1777 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co. Ltd. | Commercial: SARS-CoV-2/Influenza A/B/RSV Antigen Rapid Test Kit | Device ID: 24740 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co Ltd | Commercial: SARS-CoV-2/RSV/Adenovirus/Influenza A+B Antigen Combo Rapid Test Kit | Device ID: 25663 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co.,Ltd. | Commercial: SARS-CoV-2/RSV/Adenovirus/M.pneumoniae/ Influenza A+B Antigen Combo Rapid Test Kit | Device ID: 25664 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Fanttest Biotech Co Ltd | Commercial: SARS-CoV-2/RSV/Influenza A+B Antigen Combo Rapid Test Kit | Device ID: 25662 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Realy Tech Co., Ltd. | Commercial: SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab) | Device ID: 3964 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2（ COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method) | Device ID: 2491 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method) | Device ID: 2145 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: AMPER Inc. | Commercial: SC2Flu Triplex Fast Test (Colloidal Gold) For SARS-CoV-2 & influenza A/B antigens | Device ID: 2872 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ScheBo Biotech | Commercial: ScheBo SARS CoV-2 Quick Antigen | Device ID: 1201 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ScheBo Biotech | Commercial: ScheBo SARS CoV-2 Quick ANTIGEN (Colloidal Gold Method) | Device ID: 2763 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: InBios International | Commercial: SCoV-2 Ag Detect Rapid Test | Device ID: 1421 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: SCREEN TEST COVID-19 IgG/IgM - 2019-nCoV IgG/IgM Rapid Test Cassette | Device ID: 1787 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: SCREEN TEST COVID-19 SALIVA | Device ID: 1847 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: CAMP MEDICA DISTRIBUTION | Commercial: See Now Coronavirus nCoV antigen test | Device ID: 1999 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Senova Gesellschaft für Biowissenschaft und Technik | Commercial: Senova Greenlight | Device ID: 1818 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-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