| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: CIGA Healthcare Ltd. | Commercial: Suresign Professional Covid-19 Antigen Rapid Test Cassette (Oral Fluid) | Device ID: 1976 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: CIGA Healthcare Ltd. | Commercial: Suresign Professional 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood, Serum, Plasma)) | Device ID: 1978 | Method: Immunoassay | Target: IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID19 IgM/IgG Rapid Test Cassette | Device ID: 749 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID-19 Antigen Rapid Test Cassette | Device ID: 1275 | Method: Immunoassay | Target: Antigen | Format: 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: Nanjing Liming Bio-Products Co., Ltd. | Commercial: StrongStep® SARS-CoV-2 Antigen Rapid Test | Device ID: 2301 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Nanjing Liming BioProducts Co., Ltd | Commercial: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) | Device ID: 1224 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sentinel CH | Commercial: STAT-NAT Covid-19 HK | Device ID: 353 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sentinel CH | Commercial: STAT-NAT Covid-19 B | Device ID: 1436 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD Q COVID-19 IgM/IgG Duo Test | Device ID: 346 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD Q COVID-19 Ag Test Nasal | Device ID: 2052 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD Q COVID-19 Ag Test | Device ID: 345 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD M nCoV Real-Time Detection Kit | Device ID: 343 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD F COVID-19 Ag FIA | Device ID: 344 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Liming Bio-Products Co., Ltd | Commercial: SrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit | Device ID: 262 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sona Nanotech | Commercial: Sona Nanotech COVID-19 Lateral Flow Assay Lateral flow screening test for S1 domain of SARS-CoV-2 S1 protein | Device ID: 502 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ZET medikal tekstil dis tic ltd sti | Commercial: SOFTEC Sars Cov-2 (Covid-19) Antigen Test Kit | Device ID: 2226 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Quidel Corporation | Commercial: Sofia SARS Antigen FIA | Device ID: 1097 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgM | Device ID: 1150 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgG | Device ID: 1149 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 RBD IgA | Device ID: 1148 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgM | Device ID: 1105 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgG | Device ID: 1104 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: TestLine Clinical Diagnostics s.r.o. | Commercial: SmartEIA COVID-19 NP IgA | Device ID: 1103 | Method: Immunoassay | Target: Antibody, IgA | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Genesystem, Co. Ltd | Commercial: SMARTCHEK SARS-CoV2 Detection Kit | Device ID: 853 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Cell ID Pte Ltd | Commercial: Smart COVID-19 IgM/IgG RDT | Device ID: 838 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: APLUS Diagnostics Laboratuvar San.Tic.A.S. | Commercial: SMARAPIDTEST | Device ID: 1344 | Method: Immunoassay | Target: Antibody, Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc | Commercial: SINGUWAY COVID-19 Ag Test | Device ID: 1650 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Hangzhou Singclean Medical Products Co., Ltd | Commercial: Singclean | Device ID: 1974 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: DiaSorin S.p.A | Commercial: Simplexa COVID-19 Direct RT-PCR Kit | Device ID: 471 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: 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: OZO Life | Commercial: Simcere Novel Coronavirus (2019-NCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 860 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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 | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Sienna COVID-19 IgG/IgM Rapid Test Cassette | Device ID: 1039 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: DyonMed SA | Commercial: SieloCovidAg | Device ID: 2007 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech, Inc | Commercial: SGTi-flex COVID-19 IgM/IgG (RDT) | Device ID: 388 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech, Inc | Commercial: SGTi-flex COVID-19 Ag | Device ID: 1114 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech, Inc | Commercial: SGT anti-SARS-CoV-2 total Ab ELISA | Device ID: 1113 | Method: ELISA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody) | Device ID: 2028 | Method: Immunochromatography | Target: Antibody, IgG | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics Pte Ltd | Commercial: SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) | Device ID: 2003 | Method: Immunochromatography | Target: Antigen | Format: 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: Shenzhen Mindray Bio-Medical Electronics Co., Ltd | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA) | Device ID: 1072 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd | Commercial: Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA) | Device ID: 1071 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | 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: Secutronic Technology Co.,Ltd | Commercial: SETRO | Device ID: 1152 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Epigentek Group Inc | Commercial: SeroFlash SARS-CoV-2 IgG/IgM ELISA Fast Kit | Device ID: 1044 | Method: ELISA | Target: Antibody, IgG, IgM | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sente Biolab | Commercial: Senteligo Covid-19 qRT PCR Detection Kit | Device ID: 352 | Method: RT-PCR | Target: Nucleic acid | 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