The First COVID-19 Detection Reagent Based on Digital PCR Technology Obtaines the Registration Certificate of Class III Medical Devices

2022-01-20

Recently, TargetingOne Corpation announcs that its independent research and development New Coronavirus (2019-nCoV) nucleic acid detection kit (fluorescent PCR method) officially received the approval of NMPA medical device (National Instrument Approval: 20223400015).

This is NMPA’s first approval for a COVID-19 detection reagent based on digital PCR technology, and it is also the world’s first officially approved testing product that uses digital PCR technology in the field of infectious diseases after review. This means the autonomous control and further maturity of this new technology.

It is reported that the product is jointly developed by TargetingOne Corpation, Tsinghua University, a number of hospitals and CDC and other units, and produced by TargetingOne Corpation.

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