| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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: Trivitron Healthcare Pvt. Ltd. | Commercial: RNAsure - Covid-19 RNA Extraction Kit | Device ID: 1120 | Method: Other | Target: Nucleic acid | Format: Other | 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 Biotechnoligies | Commercial: Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal AmplificationReal Time Fluorescence Assay) | Device ID: 2600 | Method: Other | Target: Nucleic acid | Format: Near POC / POC, Other | Go to details |
| CE Marking: Yes | Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd. | Commercial: EasyNAT COVID-19 RNA Test | Device ID: 3135 | Method: Other | Target: Nucleic acid | Format: Manual | 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: Yes | Manufacturer: Vicare Solution GmbH | Commercial: Vicare Rapid FL | Device ID: 2930 | Method: LAMP | Target: Nucleic acid | Format: Lab-based, Manual, Near POC / POC, Semi-automated | 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 |
| 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: Yes | Manufacturer: Vircell s.l. | Commercial: SARS-CoV-2/FLU/RSV REALTIME PCR KIT | Device ID: 2083 | Method: RT-PCR | Target: Nucleic acid | Format: | 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: Yes | Manufacturer: VITASSAY HEALTHCARE SL | Commercial: qPCR SARS-CoV-2 (test description in spanish and english) | Device ID: 621 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: VITASSAY HEALTHCARE SL | Commercial: Vitassay qPCR SARS-CoV-2 | Device ID: 427 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Vitro SA | Commercial: SARS-CoV-2 RT-PCR | Device ID: 630 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: VivaChek Biotech (Hangzhou) Co. Ltd. | Commercial: SARS CoV 2 RT PCR Detection Kit | Device ID: 2113 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio Inc. | Commercial: careGENE COVID-19 RT-PCR kit | Device ID: 493 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wells Bio Inc. | Commercial: careGENE N-CoV RT-PCR kit | Device ID: 494 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | 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: Yes | Manufacturer: Wizbio Solutions | Commercial: WizDx COVID-9 CrystalMix PCR Kit | Device ID: 953 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wizbio Solutions | Commercial: WizDx COVID-9 Real-time PCR Kit | Device ID: 954 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: COVID-19 & Influenza A/B Nucleic Acid Test Kit | Device ID: 3998 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan EasyDiagnosis Biomedicine Co. Ltd. | Commercial: SARS-CoV-2 nucleic acid test kit | Device ID: 431 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit | Device ID: 435 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Wuhan HealthCare Biotechnology Co. Ltd. | Commercial: Novel Coronavirus 2019-nCOV Nucleic Acid Typing Test Kit (Real-Time PCR) | Device ID: 1971 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Wuxi Shenrui Bio-pharmaceuticals Co. Ltd. | Commercial: Covflu-SR, Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection | Device ID: 436 | 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