| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 (for use on the cobas 6800/8800 Systems) | Device ID: 339 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: ROCHE Diagnostics | Commercial: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Device ID: 2761 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Near POC / POC | Go to details |
| CE Marking: Yes | Manufacturer: RTA | Commercial: SARS-CoV-2 Real Time PCR Kits | Device ID: 974 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Sacace BIOTECNOLOGIES | Commercial: SARS-CoV-2 Real-TM | Device ID: 487 | 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 | Device ID: 1836 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Sansure Biotech Inc. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 342 | Method: RT-PCR | Target: Nucleic acid | Format: 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: 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: 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: 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: 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: 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: 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: 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 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 |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: 2019-Novel Coronavirus (2019 - nCoV) RT-PCR Detection Kit | Device ID: 358 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun 2019-nCoV qPCR | Device ID: 975 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Fosun COVID-19 RT-PCR Detection Kit | Device ID: 720 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Fosun Long March Medical Science Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Real-time Isothermal Amplification kit | Device ID: 976 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Shanghai GeneoDx Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method) | Device ID: 359 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Shanghai Igenetec Diagnostics Co. Ltd. | Commercial: Novel Coronavirus SARS-CoV-2 Nucleic Acid Detection Kit (Isothermal Amplification on Microfluidic Chip) | Device ID: 360 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: Diagnostic kit for SARS-CoV-2 Nucleic Acid (Real-time PCR) | Device ID: 2487 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | Go to details |
| CE Marking: No | Manufacturer: Shanghai Kehua Bio-engineering Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Test | Device ID: 361 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shanghai Rendu Biotechnology Co. Ltd. | Commercial: AmpSure 2019-nCov RNA Assay | Device ID: 362 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: 2019-nCoV Nucleic acid Detection Kit (Real Time PCR) | Device ID: 2624 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shen Zhen Zi Jian Biotechnology Co. Ltd. | Commercial: Mutation of SARS-CoV-2 nucleic acid Detection Kit（Real Time PCR） | Device ID: 2626 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen GeneBioHealth Co. Ltd. | Commercial: SARS-CoV- Nucleic Acid Test Kit (RT-PCR) | Device ID: 947 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Freeze-Dried) | Device ID: 2086 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Gene Mutation) | Device ID: 2087 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen Lifotronic Technology Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method) | Device ID: 2613 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Shenzhen New Industries Biomedical Engineering Co. Ltd. | Commercial: Molecision SARS-CoV-2, Flu & RSV RT-PCR Assay | Device ID: 2188 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | 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: 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: 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: No | Manufacturer: SNP Biotechnology R&D Ltd. Co. | Commercial: COVID-19 Real Time PCR Kit | Device ID: 809 | Method: RT-PCR | Target: Nucleic acid | Format: 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 |
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