Nanjing Vazyme Biotech Co.Ltd(688105) covid-19 antigen detection kit has been approved with medical device registration certificate

Nanjing Vazyme Biotech Co.Ltd(688105) announced on March 11 that the new coronavirus antigen detection kit independently developed and produced by the wholly-owned subsidiary Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd. recently received the medical device registration certificate issued by the State Food and drug administration.

The company said that the kit could be used to detect New Coronavirus N antigen and S antigen in the throat swabs and nasopharyngeal swabs samples of suspected infected people in New Coronavirus. The above products are generally used for the detection of samples in the acute infection period, that is, within 7 days of symptoms of suspected people. They can be used as an auxiliary and supplement for nucleic acid detection, and cooperate with the national new coronavirus detection strategy to further improve the ability of “early detection”. At the same time, the company also reminded that the kit should not be used alone for the diagnosis of New Coronavirus infection. This product not only enriches the application scenario of New Coronavirus’s overall testing solution, helps to enhance the competitiveness of the company in related fields, but also helps China’s COVID-19 epidemic prevention and control work better.

Nanjing Vazyme Biotech Co.Ltd(688105) the good news came in time. Just tonight, the national health and Health Committee issued a notice that the State Council had issued the notice on the issuance of the COVID-19 virus antigen detection application plan (Trial) in response to the New Coronavirus pneumonia epidemic prevention and control mechanism integrated group in March 10th. It shows that the state will add antigen tests on the basis of nucleic acid detection as a supplement. According to the plan, community residents who need self-test can purchase antigen test reagents for self-test through retail pharmacies, online sales platforms and other channels.

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