| CE Marking | Manufacturer | Commercial Name | ID | Method | Target | Format | Navigate |
|---|---|---|---|---|---|---|---|
| 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 |
| CE Marking: Yes | Manufacturer: Xi'an Goldmag Nanobio Tech Co. Ltd. | Commercial: Real-Time RT-PCR assays for the detection of SARS-CoV-2 | Device ID: 437 | Method: RT-PCR | Target: Nucleic acid | Format: 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: Yes | Manufacturer: Xiamen Zeesan Biotech Co. Ltd. | Commercial: sanity 2.0 system | Device ID: 3074 | Method: RT-PCR | Target: Nucleic acid | Format: Automated | Go to details |
| CE Marking: Yes | Manufacturer: Xiamen Zeesan Biotech Co. Ltd. | Commercial: SARS-CoV-2 Test Kit | Device ID: 441 | 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: Yes | Manufacturer: Yaneng BIOscience (Shenzhen) Co. Ltd. | Commercial: COVID-19 Nucleic Acid Detection Kit (Multiplex Real Time PCR) | Device ID: 443 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: YD Diagnostics Corp. | Commercial: MolecuTech Real-Time COVID-19 | Device ID: 635 | Method: RT-PCR | Target: Nucleic acid | Format: Lab-based | Go to details |
| CE Marking: Yes | Manufacturer: Yixin Bio-Tech (Guangzhou) Co. Ltd. | Commercial: New coronavirus (SARS- Cov-2) Nucleic Acid Detection Kit(Fluorescent RT-PCR Probe Method) | Device ID: 3019 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: YouSeq Ltd. | Commercial: YouSeq SARS-COV-2 qPCR Test | Device ID: 636 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Zhuhai Haitai Biological Pharmaceutical Co. Ltd. | Commercial: Novel Coronavirus (2019-nCoV)/Flu A/Flu B Real-time Multiplex RT-PCR Kit (manual & automated lab-based) | Device ID: 455 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: No | Manufacturer: Zhuhai Livzon Diagnostics Inc. | Commercial: Diagnostic Kit for Nucleic Acid to nCoV-2019 (PCR- Fluorescence Probe) | Device ID: 457 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: Molaccu COVID-19 Detection Kit | Device ID: 2219 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 & Influenza A/B Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 2221 | Method: RT-PCR | Target: Nucleic acid | Format: | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 638 | Method: RT-PCR | Target: Nucleic acid | Format: Manual | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) | Device ID: 2204 | Method: RT-PCR | Target: Nucleic acid | Format: Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zybio Inc. | Commercial: Zybio SARS-CoV-2 Assay Kit | Device ID: 2218 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, Manual, Semi-automated | Go to details |
| CE Marking: Yes | Manufacturer: Zymo Research Corp | Commercial: Quick SARS-CoV-2 Multiplex Kit | Device ID: 1438 | Method: RT-PCR | Target: Nucleic acid | Format: Automated, 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