| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: No | Manufacturer: Specialty Diagnostic (SDI) Laboratories | Commercial: SDI SARS-CoV-2 Assay | Device ID: 748 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Spectrum for Diagnostic Industries | Commercial: (SDI) SARS-CoV-2 Qualitative Real Time PCR Kit | Device ID: 617 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: St. Petersburg Research Institute of Vaccines and Sera (FSUE SPbSRIVS FMBA) | Commercial: SARS-CoV-2 Tru-EIA | Device ID: 379 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Stanford Clinical Virology Laboratory | Commercial: SARS-CoV-2 RT-PCR test | Device ID: 380 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Star Array Ptd. Ltd. | Commercial: 8-minute RT-qPCR direct PCR testing system for SARS-CoV-2 detection | Device ID: 381 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: STILLA | Commercial: COVID-19 Multiplex Crystal Digital PCR detection kit | Device ID: 382 | Method: Digital-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Sultan lab | Commercial: Leucia immune | Device ID: 2931 | Method: Other | Target: Antibody, Antigen, IgA, IgG, IgM | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Suzhou BTA Biotech Co. Ltd. | Commercial: Real time RT-PCR Kit for the detection of SARS-CoV-2 | Device ID: 393 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Suzhou Kangheshun Medical Technology | Commercial: SARS-CoV-2 IgG/IgM Rapid Test Cassette | Device ID: 696 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: SYN LAB | Commercial: Test detection Coronavirus (COVID-19) | Device ID: 394 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Sys2diag | Commercial: EasyCOV | Device ID: 1045 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TargetingOne | Commercial: Novel Coronavirus (SARS-CoV-2) nucleic acid detection kit (Digital PCR method) | Device ID: 398 | Method: Digital-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TD diagnostics | Commercial: 2019-nCoV IgG/IgM Rapid Test | Device ID: 1628 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Telepoint Medical Services LLC | Commercial: Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test | Device ID: 399 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tersaco AG | Commercial: SARS CoV-2 IgG/IgM Rapid Test | Device ID: 1030 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tetracore Inc. | Commercial: Multiplex detection and differentiation SARS-Cov-2 Serology Assay (manual) | Device ID: 401 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Thermo Fisher Scientific | Commercial: TaqMan SARS-CoV-2 Assay Kit v2 | Device ID: 402 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath COVID-19 Combo Kit | Device ID: 403 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Tianjin Jianbo Biological Co. Ltd. | Commercial: SARS-CoV-2 Specific IgM and IgG Test Kit (Coillodal Gold) | Device ID: 488 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Tianjin New Bay Bioresearch C | Commercial: Quik Pac II COVID-19 IgG & IgM Test | Device ID: 1631 | Method: Immunoassay | Target: Antibody, IgG, IgM | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) E-gene | Device ID: 409 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) N-gene | Device ID: 408 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: LightMix Modular SARS-CoV-2 (COVID19) RdRP-gene | Device ID: 410 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Trinity Biotech plc | Commercial: Bartels FlexTrans Medium | Device ID: 812 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: Twist Bioscience | Commercial: NGS-based target capture for SARS-CoV-2 detection and screening | Device ID: 412 | Method: Sequencing | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: United Biomedical | Commercial: UBI SARS-CoV-2 ELISA | Device ID: 698 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: University of Hong Kong | Commercial: Two single-step quantitative RT reverse transcription PCR assays for N gene and ORF1b of sarbecovirus subgenus | Device ID: 413 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: University of North Carolina Medical Center McLendon Clinical Laboratories | Commercial: COVID-19 PCR, on WHO protocol | Device ID: 414 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: University of Washington | Commercial: Tongue swab diagnosis of SARS-CoV-2 | Device ID: 415 | Method: Other | Target: Other | Format: Other | Go to details |
| CE Marking: No | Manufacturer: UPMC | Commercial: COVID-19 test | Device ID: 416 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Vela Diagnostics | Commercial: Great Basin System SARS-CoV-2 Direct Test | Device ID: 813 | Method: Immunoassay | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Vela Diagnostics | Commercial: SARS-CoV-2 Direct Test | Device ID: 193 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Verify Diagnostics Inc. | Commercial: Covid-19 IgG/IgM Antibody Test | Device ID: 628 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Viracor Eurofins | Commercial: Coronavirus SARS-CoV-2 RT-PCR assay | Device ID: 421 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Viracor Eurofins | Commercial: SARS-CoV-2 IgG ELISA Test Kit | Device ID: 1622 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Viracor Eurofins | Commercial: SCoV-2 DetectTM IgM ELISA | Device ID: 1624 | Method: ELISA | Target: Antibody | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Vircell s.l. | Commercial: AMPLIRUN CORONAVIRUS SARS (2003) RNA CONTROL | Device ID: 490 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Vircell s.l. | Commercial: SARS-COV-2 REALTIME PCR KIT | Device ID: 426 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Automated | Go to details |
| CE Marking: No | Manufacturer: Vircell s.l. | Commercial: SARS-COV-2 VARIANTS REALTIME PCR KIT | Device ID: 2084 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Automated | Go to details |
| CE Marking: No | Manufacturer: Vision Biotechnology Research & Development | Commercial: VISION COVID19 Easyprep Test Kit | Device ID: 492 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Vision Biyoteknoloji AraÅŸtırma GeliÅŸtirme Laboratuvar Sistemleri Sanayi ve Ticaret Limited Åžirketi | Commercial: VISION® COVID-19 AG RAPID TEST | Device ID: 2070 | Method: Immunoassay | Target: Antigen | Format: Manual, Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Vyttra Diagnosticos | Commercial: Smart Test Covid-19 Vyttra | Device ID: 631 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Wells Bio Inc. | Commercial: careUS COVID-19 IgM/IgG | Device ID: 632 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Wizbio Solutions | Commercial: WizDx Covid-19 Crytsal Mix PCR Kit | Device ID: 894 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Wondfo | Commercial: COVID-19 Rapid Test, WONDFO SARS-CoV-2 Antibody Test (Lateral Flow Method) | Device ID: 687 | Method: Immunoassay | Target: Antibody | Format: Near POC / POC | Go to details |
| CE Marking: No | Manufacturer: Xfold Imaging | Commercial: Xfold immunoassay | Device ID: 1058 | Method: Immunoassay | Target: Antibody | Format: Automated, Manual | Go to details |
| CE Marking: No | Manufacturer: Xi'an Tianlong Science and Technology Co. Ltd. | Commercial: COVID-19 ORF1ab/N Gene PCR Detection Kit | Device ID: 442 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Yale New Haven Hospital Clinical Virology Laboratory | Commercial: SARS-CoV-2 PCR test | Device ID: 753 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: No | Manufacturer: Yantai Addcare Bio-Tech | Commercial: Fully Automated Nucleic Acid Extractor | Device ID: 1897 | Method: Other | Target: Nucleic acid | Format: Fully automated (robot) | Go to details |
| CE Marking: No | Manufacturer: Yantai Addcare Bio-Tech | Commercial: Fully Automated Nucleic Acid Extractor (magnetic beads adsorption) | Device ID: 1898 | Method: Other | Target: Nucleic acid | Format: Other | 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