| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: Yes | Manufacturer: ScheBo Biotech | Commercial: ScheBo SARS-CoV-2 Quick | Device ID: 798 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Schweitzer Biotech Company Ltd. | Commercial: SBC RNP qPCR Kit | Device ID: 799 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Schweitzer Biotech Company Ltd. | Commercial: SBC SARS-CoV-2 Convective PCR Diagnostic Device/Kit | Device ID: 801 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Schweitzer Biotech Company Ltd. | Commercial: SBC SARS-CoV-2 qPCR Kit | Device ID: 800 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: ScienCell Research Laboratories | Commercial: ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit | Device ID: 746 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Scope Fluidics SA | Commercial: PCR|COV | Device ID: 604 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: Screen Test Covid-19 - 2019-NCoV IgG/IgM Rapid Test Cassette | Device ID: 992 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST | Device ID: 1681 | Method: Immunoassay | 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: SCREEN ITALIA S.r.l. | Commercial: Screentest Covid-19+FLU A/B | Device ID: 1590 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD Biosensor Healthcare Private Limited | Commercial: Ultra COVID-19 Ag | Device ID: 3026 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | 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: SD BIOSENSOR Inc. | Commercial: STANDARD F COVID-19 Ag FIA | Device ID: 24759 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD F COVID/Flu Ag Combo FIA | Device ID: 24757 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc. | Commercial: STANDARD i-Q COVID/Flu Ag Combo Test | Device ID: 24756 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 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 Q COVID-19 Ag Test 2.0 | Device ID: 24758 | Method: Immunochromatography | Target: Antigen | Format: Manual | 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 IgM/IgG Duo Test | Device ID: 346 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: AQ-TOP COVID-9 Rapid Detection Kit | Device ID: 944 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: U-TOP COVID-19 Detection Kit | Device ID: 347 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Seegene Inc. | Commercial: Allplex 2019-nCoV assay | Device ID: 348 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Seegene Inc. | Commercial: Allplex SARS-CoV-2 Assay | Device ID: 1128 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Selfdiagnostics Deutschland GmbH | Commercial: Multitest COVID-19 | Device ID: 4056 | Method: LAMP | Target: DNA, Nucleic acid, RNA | Format: Lab-based, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Selfdiagnostics Deutschland GmbH | Commercial: SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva) | Device ID: 1895 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39501-Recombinant SARS-CoV-2 Nucleocapsid Protein | Device ID: 605 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39502-Recombinant SARS-CoV-2 Spike Protein | Device ID: 606 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39503-Recombinant SARS-CoV-2 Spike (R682S) Protein | Device ID: 607 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39504-Recombinant SARS-CoV-2 Envelope Protein | Device ID: 608 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39505-Recombinant SARS-CoV (2004) Nucleocapsid Protein | Device ID: 609 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39506-Recombinant MERS-CoV Nucleocapsid Protein | Device ID: 610 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39507-Recombinant Influenza A and B Ha Protein | Device ID: 611 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39508R-Sengenics Respiratory Virus Protein Microarray | Device ID: 612 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: 39509-Sengenics High-throughput, High Multiplex Microtitre Assay | Device ID: 613 | Method: Immunoassay | Target: Antibody, Antigen | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Sengenics Corporation Pte Ltd. | Commercial: CoviDx | Device ID: 350 | Method: Immunoassay | Target: Antibody | Format: Automated, 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 |
| CE Marking: Yes | Manufacturer: Sense Biodetection Limited | Commercial: Veros™ COVID-19 | Device ID: 3067 | Method: | Target: Nucleic acid | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401) | Device ID: 870 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: EDR COVID 19 Rapid Test Kit (IgM/IgG) | Device ID: 351 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: Novel Coronavirus Neutralizing Antibody Rapid Test Kit | Device ID: 2040 | Method: Immunochromatography | Target: Antibody | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: S1 Covid-19 Rapid Antigen Test Kit | Device ID: 1493 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd. | Commercial: S2 Covid-19 Rapid Antigen Test Kit | Device ID: 2039 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensitest | Commercial: Sensitest Joysbio Antigen Rapid Test for Covid-19 | Device ID: 1272 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensiva Health LLC | Commercial: Sensiva Health React Rapid Antigen Test (Lateral Flow Method) | Device ID: 2611 | Method: Immunoassay | Target: Antigen, IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensiva Health LLC | Commercial: Sensiva Health Spectrum Rapid COVID-19 Antigen Test | Device ID: 2610 | Method: Immunoassay | Target: IgG | 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