| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Dimension Vista SARS-CoV-2 IgG (CV2G) | Device ID: 2025 | Method: Immunoassay | Target: IgG | Format: Lab-based, Other | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: Fast Track Diagnostics (FTD) SARS-CoV-2 Assay | Device ID: 747 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: SARS-CoV-2 Total (COV2T) assay | Device ID: 1049 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sigmed Sp. z o.o. | Commercial: Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag) | Device ID: 2256 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Silversite diagnostics.corp | Commercial: Antibody kit igg igm testing | Device ID: 1731 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: simin.chen@lifotronic.com | Commercial: Nucleic Acid Extraction Reagent | Device ID: 2614 | Method: | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc. | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Device ID: 1155 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc. | Commercial: Nucleic Acid Detection Kit For COVID-19 (PCR Fluorescence Probe) | Device ID: 1154 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | 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: Sinocare | Commercial: SARS-CoV-2 Antibody Test strip (colloidal Gold Method) | Device ID: 990 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SLSBio Co. Ltd. | Commercial: SsmarTest COVID-19 Ag Detection Kit | Device ID: 2630 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SLSBio Co. Ltd. | Commercial: SSmarTest COVID19 Spike Protein Ab(IgM/IgG) Test | Device ID: 2631 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI 2019-nCoV IgG (CLIA) | Device ID: 374 | Method: Immunoassay | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI 2019-nCoV IgM (CLIA) | Device ID: 375 | Method: Immunoassay | Target: Antibody, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA) | Device ID: 1491 | Method: CLIA | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) | Device ID: 1299 | Method: CLIA | Target: Antibody, IgG | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: Molecision SARS-CoV-2 & Flu A/B RT-PCR Assay | Device ID: 1492 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Snibe Co. Ltd. | Commercial: Molecision SARS-CoV-2 RT-PCR Assay | Device ID: 1206 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ COVID-19 (N, ORF1a) Detection Kit | Device ID: 2493 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ Flu A/B & SARS-CoV-2 Detection Kit | Device ID: 2944 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit | Device ID: 376 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ RV16 Detection Kit (with SARS-CoV-2) | Device ID: 5786 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ SARS-CoV-2 (N, ORF1a, RdRp) Fast Detection Kit | Device ID: 2945 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Solsten Diagnostics Intl. ApS | Commercial: Solsten SARS-CoV-2 Antigen ELISA Kit | Device ID: 2559 | Method: ELISA | Target: Antigen | Format: Automated, Manual, Semi-automated | 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: SPAN BIOTECH Ltd. | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2817 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPAN BIOTECH Ltd. | Commercial: COVID-19(SARS-CoV-2) Antigen Test Kit (Nasal Swab) | Device ID: 2819 | Method: | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check - COVID-19 IgG/IgM Test | Device ID: 1086 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check DIRECT Covid-19 Antigen Test | Device ID: 1196 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spartacus-Biomed | Commercial: COVID-19 Antigen Rapid Test | Device ID: 2185 | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Spartacus-Biomed | Commercial: LFA COVID-19 IgG & IgM Rapid Test Device | Device ID: 2186 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SpeeDx | Commercial: PlexPCR® SARS-CoV-2 | Device ID: 2825 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: Covid-19 Antigen Rapid Test Cassette | Device ID: 2246 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 AG/Influenza A&B Combo Rapid Test Cassette | Device ID: 2617 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 Antibody IgG-IgM Rapid Test Cassette | Device ID: 2616 | Method: Immunochromatography | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPESERA SAĞLIK ÜRÜNLERİ İÇ VE DIŞ Ltd. ŞTİ. | Commercial: SPESERA Covid-19 Antibody Neutralizing Rapid Test Cassette | Device ID: 2615 | Method: Immunochromatography | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spindiag GmbH | Commercial: Rhonda Corona test | Device ID: 810 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: SPRING HEALTHCARE SERVICES SP Z O O | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Device ID: 618 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPRING HEALTHCARE SERVICES SP Z O O | Commercial: SARS-Cov-2 Antigen Rapid Test Cassette (Saliva) | Device ID: 1901 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SPRING HEALTHCARE SERVICES SP Z O O | Commercial: SARS-Cov-2 Antigen Rapid Test Cassette (Swab) | Device ID: 1780 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: STAB VIDA | Commercial: Dr Vida pocket for COVID-19 | Device ID: 1993 | Method: LAMP | Target: Nucleic acid | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: STARK S.A.R.L | Commercial: Stark Portable COVID-19 Antigen Lab | Device ID: 2554 | Method: ELISA | Target: Antigen | Format: Manual | 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: Sugentech Inc. | Commercial: SGTi-flex COVID-19 Ag | Device ID: 1114 | 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: 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: Sure Bio-Tech (USA) Co. Ltd. | Commercial: Diagnostic Kit for SARS-CoV-2 Ag (Fluorescence Immunochromatographic Assay) | Device ID: 1274 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: SARS-CoV-2 IgG Ab Rapid Test | Device ID: 392 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: SARS-CoV-2 IgM Ab Rapid Test | Device ID: 391 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sure Bio-Tech (USA) Co. Ltd. | Commercial: SARS-CoV-2 IgM/IgG Ab Rapid Test | Device ID: 390 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: 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