New coronavirus detection reagents belong to several types of medical devices

What kind of medical device does the new Pneumonia virus detection reagent belong to? Let’s take a look at the authoritative answer given by the National Medical Products Administration

Pneumonia Detection Reagent

The picture shows the medical device products registered by Shanghai Fuxing Long March Medical Science Co., Ltd.
The product name is: New Coronavirus (2019-nCoV) nucleic acid detection kit (fluorescent PCR method)
Management level: The third category (Class III medical devices), the highest level of medical devices, of course, very important medical devices such as virus detection reagents must of course belong to the highest level

Therefore, the new Coronary Pneumonia virus detection reagent belongs to Class III (Class III) medical devices

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