| CE Marking | Manufacturer | Commercial Name | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: Rapigen Inc. | Commercial: BIOCREDIT COVID-19 Ag - SARS-CoV 2 Antigen test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Rapigen Inc. | Commercial: BIOCREDIT COVID-19 IgG/IgM Combo | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Rapigen Inc. | Commercial: RapiGEN Inc. | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: RayBiotech | Commercial: Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RDSM nv | Commercial: COVID-19 Antigen test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Redcell Biyoteknoloji A.Ş | Commercial: COVID-19 Antigen Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Redcell Biyoteknoloji A.Ş | Commercial: Direct RT-qPCR SARS-CoV-2 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Redcliffebio | Commercial: LightPower iVASARS-CoV-2 1st RT-rPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ring Biotechnology Co., Ltd | Commercial: COVID-19 IgM/IgG Rapid Test Kit | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Roche (SD BIOSENSOR) | Commercial: SARS-CoV-2 Antigen Rapid Test | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 (for use on the cobas 6800/8800 Systems) | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: Elecsys Anti-SARS-CoV-2 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: RTA | Commercial: SARS-CoV-2 Real Time PCR Kits | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sacace BIOTECNOLOGIES | Commercial: SARS-CoV-2 Real-TM | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SACEM Hayat Teknolojileri A.S. | Commercial: iNADx Multiplex III COVID-19 RT-qPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd | Commercial: 2019-nCoV IgG/IgM Rapid Test Device | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd | Commercial: COVID-19 Antigen Rapid Test Kit (Swab) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co. Ltd | Commercial: Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19) | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd. | Commercial: COVID-19 Antigen Rapid Test Kit(Saliva) | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Salocor COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Salofa Oy | Commercial: Sienna COVID-19 IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech, Inc | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: ScheBo Biotech AG | Commercial: ScheBo SARS CoV-2 Quick Antigen | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: ScheBo Biotech AG | Commercial: ScheBo SARS-CoV-2 Quick | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Schweitzer Biotech Company Ltd | Commercial: SBC SARS-CoV-2 qPCR Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SCREEN ITALIA S.r.l. | Commercial: Screentest Covid-19+FLU A/B | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Screen Italia SRL | Commercial: Screen Test Covid-19 - 2019-NCoV IgG/IgM Rapid Test Cassette | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Screen Italia SRL | Commercial: SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Screen Italia SRL | Commercial: SCREEN TEST COVID-19 IgG/IgM - 2019-nCoV IgG/IgM Rapid Test Cassette | Method: Immunochromatography | Target: IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Screen Italia SRL | Commercial: SCREEN TEST COVID-19 SALIVA | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD F COVID-19 Ag FIA | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SD BIOSENSOR Inc | Commercial: STANDARD M nCoV Real-Time Detection Kit | 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 | 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 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: AQ-TOP COVID-9 Rapid Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SEASUN BIOMATERIALS | Commercial: U-TOP COVID-19 Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Secutronic Technology Co.,Ltd | Commercial: SETRO | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Seegene, Inc | Commercial: Allplex 2019-nCoV assay | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Selfdiagnostics Deutschland GmbH | Commercial: SARS-CoV-2 Antigen Rapid Test | Method: Immunochromatography | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Senova Gesellschaft für Biowissenschaft und Technik mbH | Commercial: Senova Greenlight | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC, Semi-automated | Go to details |
| 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: COVID-19 Rapid IgG/IgM Combined Antigen Assay Pre-screening Test Kit (Model ERCSS05401) | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | 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: Sente Biolab | Commercial: Senteligo Covid-19 qRT PCR Detection Kit | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sentinel CH | Commercial: STAT-NAT Covid-19 B | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sentinel CH | Commercial: STAT-NAT Covid-19 HK | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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 |
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