| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ RV16 Detection Kit (with SARS-CoV-2) | Device ID: 5786 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: SolGent Co. Ltd. | Commercial: DiaPlexQ™ SARS-CoV-2 (N, ORF1a, RdRp) Fast Detection Kit | Device ID: 2945 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| 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: Yes | Manufacturer: SpeeDx | Commercial: PlexPCR® SARS-CoV-2 | Device ID: 2825 | Method: RT-PCR | Target: | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Spindiag GmbH | Commercial: Rhonda Corona test | Device ID: 810 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: 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: Yes | Manufacturer: Suzhou TianLong Biotechnology Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR Method) | Device ID: 2488 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based, Semi-automated | 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: Yes | Manufacturer: Synbiotik Biotech | Commercial: VoliroN SARS-CoV-2 Real-Time PCR Kit | Device ID: 2966 | Method: RT-PCR | Target: | Format: Lab-based, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Systaaq Diagnostic Prouducts | Commercial: 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit | Device ID: 395 | 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: Yes | Manufacturer: TBG Biotechnology Corp. | Commercial: ExProbe SARS-CoV-2 Testing Kit | Device ID: 1335 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TBG BIOTECHNOLOGY XIAMEN Inc. | Commercial: Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Device ID: 1339 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual | Go to details |
| CE Marking: Yes | Manufacturer: Tellgen Corporation | Commercial: SARS-CoV-2 Nucleic acid detection kit based on Cartridge Real-Time PCR platform | Device ID: 1979 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Theragen Genome Care | Commercial: Theragen COVID-19 ASSAY | Device ID: 2165 | Method: RT-PCR | Target: Nucleic acid | Format: 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: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath COVID-19 CE-IVD RT-PCR Kit | Device ID: 875 | 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: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath™ COVID-19 Fast PCR Combo Kit 2.0 | Device ID: 2950 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Thermo Fisher Scientific | Commercial: TaqPath™ COVID-19 RNase P Combo Kit 2.0 | Device ID: 2949 | 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) 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: Yes | Manufacturer: TIB Molbiol/Roche Diagnostics | Commercial: SARS-CoV-2 E, RdRP or N gene CE-IVD 7 virus Respiratory Panel multiplex RT-PCR | Device ID: 406 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TNS Co. Ltd. (BioTNS) | Commercial: COVID-19 RT-PCR PNA KIT | Device ID: 1153 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: TransGen Biotech Co. Ltd. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex Real Time RT-PCR ) | Device ID: 1750 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: COVIDsure Multiplex Realtime RT-PCR Kit | Device ID: 625 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Trivitron Healthcare Pvt. Ltd. | Commercial: COVIDsure Pro Multiplex RT PCR Kit | Device ID: 1119 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Ukrgentech | Commercial: RT-PCR test kit for COVID-9 detection | Device ID: 952 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: UPMC | Commercial: COVID-19 test | Device ID: 416 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: EasyNAT Integrated, Automated Molecular Diagnostic Assay for COVID-19 RNA | Device ID: 418 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Vector-Best | Commercial: RealBest RNA SARS-CoV-2 | Device ID: 1462 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vela Diagnostics | Commercial: ViroKey SARS-CoV-2 RT-PCR Test | Device ID: 751 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Veredus Laboratories Pte Ltd. | Commercial: VereCoV OneMix Detection Kit for VerePLEX Biosystem | Device ID: 419 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | 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: 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: Yes | Manufacturer: Vircell s.l. | Commercial: AMPLIRUN SARS-CoV-2 RNA CONTROL | Device ID: 629 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: AMPLIRUN TOTAL SARS-CoV-2 CONTROL (SWAB) | Device ID: 491 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: AMPLIRUN® TOTAL SARS-CoV-2/FluA/FluB/RSV CONTROL (SWAB) | Device ID: 4144 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Other | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: DIRECT SARS-COV-2 REALTIME PCR KIT | Device ID: 2082 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: SARS-COV-2 OMICRON REALTIME PCR KIT | Device ID: 4136 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: SARS-COV-2 PLUS UK REALTIME PCR KIT | Device ID: 4134 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Vircell s.l. | Commercial: SARS-COV-2 PLUS UK REALTIME PCR KIT | Device ID: 4135 | Method: RT-PCR | Target: Nucleic acid, RNA | Format: Automated | 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 |
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