The registration information change application of covid-19 antigen detection kit of four companies including Guangzhou Wondfo Biotech Co.Ltd(300482) , Bgi Genomics Co.Ltd(300676) and others was approved by the State Food and drug administration

According to scidev.net daily on the 12th, the pending information of medical device approval document (change) released on the website of the State Food and Drug Administration on the 12th shows that it was issued by Guangzhou Wondfo Biotech Co.Ltd(300482) , Bgi Genomics Co.Ltd(300676) subsidiaries Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd., Beijing jinwofu bioengineering technology Co., Ltd Four covid-19 antigen detection kits developed by four companies of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) Medical Technology Co., Ltd. have passed the registration information change of the food and drug administration. Professionals said that the core of the “registration change” is that the test reagent is no longer limited to “only used by professional technicians”. Other industry insiders believe that this may also mean that relevant detection reagents will be used in other scenarios such as home self-test.