| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd. | Commercial: COVID-19 Antigen Rapid Test Device（Colloidal Gold） | Device ID: 2139 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ISO13485 | Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold ) | Device ID: 2138 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: InfectCheck® COVID-19 NAb Test | Device ID: 2137 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: InfectCheck® - COVID-19 IgG/IgM Test | Device ID: 2136 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unimed International Inc. | Commercial: OnSight™- COVID-19 NAb Quantitative Test | Device ID: 2135 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 NAb Quantitative Test | Device ID: 2134 | Method: Immunochromatography | Target: IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unimed International Inc. | Commercial: OnSight™ - COVID-19 IgG/IgM Combo Test | Device ID: 2133 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 IgG/IgM Test | Device ID: 2132 | Method: Immunochromatography | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Unimed International Inc. | Commercial: OnSight™ - COVID-19 Antigen Test | Device ID: 2131 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Affimedix Inc. | Commercial: TestNOW® - COVID-19 Antigen Test | Device ID: 2130 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor SARS-CoV-2 Antigen Rapid Test Cassette | Device ID: 2129 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Lumigenex (Suzhou) Co. Ltd. | Commercial: PocRoc®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | Device ID: 2128 | 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: Macrogen | Commercial: AxenTM COVID-19 IgM/IgG RAPID | Device ID: 2126 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Macrogen | Commercial: AxenTM COVID-19 Ag RAPID | Device ID: 2125 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Fujirebio Inc. | Commercial: Lumipulse G SARS-CoV-2 Ag | Device ID: 2124 | Method: Immunoassay | Target: Antigen | Format: Automated, Fully automated (robot), Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: MICROTRACE DIAGNOSTICI | Commercial: SARS-CoV-2 Antigen Rapid Test | Device ID: 2123 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: BIO GROUP MEDICAL SYSTEM | Commercial: COVID-19 ANTIGEN RAPID TEST CASSETTE | Device ID: 2122 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Sampling by gargle or oropharyngeal wash) | Device ID: 2121 | 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: 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: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS CoV 2 Ag Saliva Rapid Test | Device ID: 2118 | Method: Immunochromatography | Target: Antigen | 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: PerGrande BioTech Development Co. Ltd. | Commercial: SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) | Device ID: 2116 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sanwa Biotech Limited | Commercial: ALiA SARS-CoV-2 Antigen FIA Test | Device ID: 2115 | Method: Immunoassay | Target: Antigen | 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: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS CoV 2 RT PCR Detection Kit | Device ID: 2113 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: GenSure Biotech Inc. | Commercial: GenSure COVID-19 Neutralizing Antibody Test (Latex) | Device ID: 2112 | Method: Immunoassay | Target: Antibody | Format: | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS-CoV-2 Ag Rapid Test | Device ID: 2111 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Therma Bright Inc. | Commercial: AcuVid COVID-19 Rapid Antigen Saliva Test | Device ID: 2110 | Method: Immunoassay | Target: Antigen | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lvshiyuan Biotechnology Co. Ltd. | Commercial: Green Spring SARS-CoV-2 Antigen-Rapid test-Set | Device ID: 2109 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AESKU.DIAGNOSTICS GmbH & Co. KG | Commercial: AESKU.RAPID SARS-CoV-2 | Device ID: 2108 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Jiangsu Bioperfectus Technologies Co. Ltd. | Commercial: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit | Device ID: 2107 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS-CoV-2 Neutralizing Antibody FIA Test Kit | Device ID: 2106 | Method: Immunochromatography | Target: Antibody | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS-CoV-2 Ag FIA Test | Device ID: 2105 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Nal von minden GmbH | Commercial: NADAL COVID-19 Ag + Influenza A/B Test | Device ID: 2104 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Pro SARS CoV 2 Ag Rapid Test | Device ID: 2103 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag SARS-CoV-2 Ag Rapid Test | Device ID: 2102 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: AXIOM Gesellschaft für Diagnostica und Biochemica mbH | Commercial: COVID-19 Antigen Rapid Test Card | Device ID: 2101 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: Verino Pro SARS CoV 2 Ag Rapid Test | Device ID: 2100 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: VivaDiag Pro SARS CoV 2 Ag Rapid Test (self test) | Device ID: 2099 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: COVID-19 (SARS-CoV-2) Antigen Test Kit | Device ID: 2098 | 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 (Colloidal Gold Method) | Device ID: 2097 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Diasia Biomedical Technology Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 2096 | Method: Immunochromatography | Target: Antigen | Format: | 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: LT Biotech JSC | Commercial: COVID19AgLTFLOW | Device ID: 2094 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-2019-nCoV | Device ID: 2093 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY ABFlu-CoV-2 | Device ID: 2092 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Fully automated (robot), Manual | Go to details |
| CE Marking: Yes | Manufacturer: AB ANALITICA | Commercial: REALQUALITY RQ-SARS-CoV-2 | Device ID: 2091 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan UNscience Biotechnology Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test Kit | Device ID: 2090 | Method: Immunochromatography | Target: Antigen | Format: Lab-based, 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