On March 12, the State Food and Drug Administration issued a notice approving the change of covid-19 antigen product self-test application of Nanjing Nanjing Vazyme Biotech Co.Ltd(688105) , Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) , Beijing huaketai biology. Since then, five self-test products of vid-19 antigen have been officially launched.
Guangzhou Wondfo Biotech Co.Ltd(300482) , located in Whampoa District of Guangzhou, is the only enterprise that has obtained double registration certificate of COVID-19 antigen detection and COVID-19 antibody detection in China. The New Coronavirus Guangzhou Wondfo Biotech Co.Ltd(300482) (2019-nCoV) antigen detection kit (colloidal gold method) is one of the first certified COVID-19 virus antigen reagents in China, and has been certified by the EU CE and the local qualification of the relevant importers.
It is reported that in September 2020, Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen detection reagent obtained the EU CE certification, and Guangzhou Wondfo Biotech Co.Ltd(300482) covid-19 antigen self-test product also obtained the EU CE certification in June 2021, which is convenient for individuals and families to carry out the rapid detection of covid-19 virus and give results in 15 minutes.