| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Sensing Self Pte. Ltd | Commercial: S1 Covid-19 Rapid Antigen Test Kit | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SensingSelf, Pte, Ltd, Singapore | Commercial: EDR COVID 19 Rapid Test Kit (IgM/IgG) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sensitest The Netherlands BV | Commercial: Sensitest Joysbio Antigen Rapid Test for Covid-19 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: servoprax GmbH | Commercial: Cleartest Corona, Covid-19 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA MÜHENDİSLİK DANIŞMANLIK EĞİTİM İÇ VE DIŞ TİC. A.Ş. | Commercial: V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA MÜHENDİSLİK DANIŞMANLIK EĞİTİM İÇ VE DIŞ TİC. A.Ş. | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA MÜHENDİSLİK DANIŞMANLIK EĞİTİM İÇ VE DIŞ TİC. A.Ş. | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (IFA) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHANDONG KANGHUA BIOTECHNOLOGY CO., LTD | Commercial: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai B&C Biological Technology | Commercial: SARTS-CoV2 IgM/IgG antibody test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd | Commercial: 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd | Commercial: nCoV IgG/IgM combo test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai International Holding Corp. GmbH(Europe) (DE) | Commercial: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Outdo Biotech Co., Ltd | Commercial: Novel Coronavirus (SARS-CoV-2) Antibody (IgM / IgG) Test (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd | Commercial: Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd | Commercial: Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen GeneBioHealth Co., Ltd | Commercial: SARS-CoV- IgM IgG Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Highcreation Technology Co., Ltd | Commercial: Novel Corona- virus IgM/IgG Combo Rapid Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd | Commercial: SARS-CoV-2 IgG & IgM Antibody Combined Test Kit (Colloidal Gold Chromatographic Immunoassay) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Microprofit Biotech Co., Ltd | Commercial: SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Reagent Technology Co., Ltd | Commercial: COVID-19 IgG/IgM Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Watmind Medical Co., Ltd | Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV IgA | Method: Immunoassay | Target: Antibody, IgA | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: GLINE-2019-nCoV NAb | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd | Commercial: UNICELL-2019-nCoV Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Zhenrui Biotechnology Co., Ltd | Commercial: Zhenrui ®COVID-19 Antigen Test Cassette | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 Antigen Assay kit by Latex Immunochromatography method | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 IgG/IgM Antibody Assay Kit by Immunofluorescence Chromatography Method | Method: Chromatography | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sichuan Xincheng Biological Co., LTD | Commercial: SARS-Cov-2 IgG/M Antibody Assay kit by Colloidal Gold Method | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Siemens Healthineers | Commercial: CLINITEST Rapid Covid-19 Antigen Test | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH Inc | Commercial: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SINGUWAY BIOTECH INC. | Commercial: SINGUWAY COVID-19 Ag Test | 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) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | 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 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check - COVID-19 IgG/IgM Test | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spark Diagnostics LLC | Commercial: CoV-Check DIRECT Covid-19 Antigen Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spring Healthcare Services AG | Commercial: COVID-19 IgG/IgM Rapid Test (colloidal gold-based) | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Spring Healthcare Services AG | Commercial: SARS-Cov-2 Antigen Rapid Test Cassette (swab) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech, Inc | Commercial: SGTi-flex COVID-19 Ag | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sugentech, Inc | Commercial: SGTi-flex COVID-19 IgM/IgG (RDT) | 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) | 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) | 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 | Method: Immunoassay | Target: Antibody | 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 | Method: Immunoassay | Target: Antibody | 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 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: Rapid Immunoassay Test Cassette | 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 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SureScreen Diagnostics | Commercial: SureScreen COVID19 IgM/IgG Rapid Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Swedicine AB | Commercial: Covid-19 Antigen Rapid Test Cassette | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Syrona Limited | Commercial: COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: T&D diagnostics Canada Pvt., Canada | Commercial: COVID-19 Antigen Rapid Test, Sienna | Method: Immunoassay | Target: Antigen | 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