| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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 |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | Commercial: STAT-NAT Covid-19 B | Device ID: 1436 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | 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. SpA | Commercial: STAT-NAT® SARS-CoV-2 - 1N044 | Device ID: 3031 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | Commercial: STAT-NAT® SARS-CoV-2 SN200 - 1N045S | Device ID: 2981 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: SENTINEL CH. SpA | Commercial: STAT-NAT® SARS-CoV-2 – 1N045 | Device ID: 3032 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: servoprax GmbH | Commercial: Cleartest Corona, Covid-19 | Device ID: 354 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 IgG/IgM Rapid Test Kit | Device ID: 2543 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity IgG/IgM Rapid Test Kit | Device ID: 2542 | Method: Immunochromatography | Target: IgG, IgM | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics COVID-19 Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | Device ID: 2544 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | 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 | Commercial: SG Diagnostics Dual Immunity Rapid Test Kit (anti-Spike RBD IgG and anti-Nucleocapsid Protein Antibodies) | Device ID: 2541 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | Device ID: 2540 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics | Commercial: SG Diagnostics Saliva Antigen Rapid Test Kit | Device ID: 2539 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics Pte Ltd. | Commercial: SG Diagnostics COVID-19 and Influenza A/B Rapid Test Kit | Device ID: 2564 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | 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: SG Diagnostics Pte Ltd. | Commercial: SG Diagnostics COVID-19 Dual Immunity Rapid Test Kit (anti-Spike RBD IgG and anti-Nucleocapsid Protein Antibodies) | Device ID: 2561 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics Pte Ltd. | Commercial: SG Diagnostics COVID-19 Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody) | Device ID: 2562 | Method: Immunochromatography | Target: IgG | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Diagnostics Pte Ltd. | Commercial: SG Diagnostics COVID-19 Saliva Rapid Test Kit | Device ID: 2563 | Method: Immunochromatography | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SG Medical Inc. | Commercial: InstaView COVID-19 Antigen | Device ID: 2935 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) | Device ID: 1319 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold) | Device ID: 1357 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal | Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (IFA) | Device ID: 1317 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: SGA Medikal ( SGA Muhendislik Dans Egt Ic ve Dis Tic A.S.) | Commercial: ViruScan SARS-CoV-2 Rapid Antigen Test | Device ID: 5732 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shaanxi Lifegen Co. Ltd. | Commercial: Novel coronavirus (COVID-19) nucleic acid detection kit (fluorescent PCR method) | Device ID: 355 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SHANDONG KANGHUA BIOTECHNOLOGY Co. Ltd. | Commercial: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) | Device ID: 1366 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Shandong Shtars Biological Industry Co. Ltd. | Commercial: Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit User Manual | Device ID: 356 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shandong ThinkLab Biotechnology Co. Ltd. | Commercial: 09-nCOV IgM/IgG antibody test kits (Colloidal-gold Assay) | Device ID: 945 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shandong ThinkLab Biotechnology Co. Ltd. | Commercial: Coronavirus Ag Rapid Test Cassette (Swab) | Device ID: 2154 | Method: Immunochromatography | 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 | Device ID: 1015 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: BioGerm SARS-CoV-2 Antigen Self Test | Device ID: 3039 | Method: Immunochromatography | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) | Device ID: 2167 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold) | Device ID: 2178 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai BioGerm Medical Technology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) | Device ID: 2019 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Bionaire Biotech Co. Ltd. | Commercial: Novel Coronavirus (COVID-19) Antigen Test (Colloidal Gold) | Device ID: 2577 | Method: Immunochromatography | Target: Antigen | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) | Device ID: 2312 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold) | Device ID: 2313 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 （SARs-Cov-2）Antigen Rapid Test Kit (Nasal Swab) | Device ID: 2512 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit (Nasal Swab) | Device ID: 3072 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19 （SARs-Cov-2）Antigen Rapid Test Kit (Saliva) | Device ID: 2511 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold) | Device ID: 2314 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold) | Device ID: 2307 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold) | Device ID: 2308 | Method: Immunoassay | Target: Antigen | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® COVID-19（SARS-CoV-2）Antigen Rapid Test Kit (Nasal Swab) - self-test | Device ID: 3080 | Method: Immunoassay | Target: Antigen | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgG Antibody Diagnostic Kit (Colloidal Gold) | Device ID: 2516 | Method: Immunoassay | Target: Antibody, IgG | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgM Antibody Diagnostic Kit （Colloidal Gold) | Device ID: 357 | Method: Immunoassay | Target: Antibody, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: Chemtrue® Novel Coronavirus(2019-nCoV) IgM/IgG Antibody Diagnostic Kit (Colloidal Gold) | Device ID: 2311 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chemtron Biotech Co. Ltd. | Commercial: nCoV IgG/IgM combo test | Device ID: 1023 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Chuangkun Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV）RT-PCR Detection Kit (Lyophilized) | Device ID: 2421 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Conlight Medical Lab Co. Ltd. | Commercial: SARS-CoV-2/FluA/FluB/RSV detection kit（PCR MALDI-TOF-MS） | Device ID: 1821 | Method: Other | Target: Nucleic acid | Format: Lab-based | 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