Wantai Biotech (603392.SH): HIV antibody oral mucosal exudate self-test reagent obtained medical device registration certificate

Zhitongcaijing · 2d ago

Zhitong Finance App News, Wantai Biotech (603392.SH) issued an announcement. Recently, the company's self-developed human immunodeficiency virus (HIV1+2 type) antibody oral mucosal exudate test kit (colloidal gold method) obtained the “People's Republic of China Medical Device Registration Certificate (in vitro diagnostic reagent)” issued by the State Drug Administration.

This product is the first test kit approved in China for self-testing human immunodeficiency virus (HIV1+2) antibodies in oral mucosal exudates. This is another HIV test kit approved by the company after the human immunodeficiency virus type 1 urine antibody test kit (colloidal gold method) and the human immunodeficiency virus (HIV1+2 type) antibody test kit (colloidal gold method). An upgraded version of the urine autotest kit for human immunodeficiency virus type 1+2 antibody urine test kit (colloidal gold method) Get approved simultaneously. It marks that the company's technological leadership and innovation ability in the field of HIV self-testing have once again been recognized by national authorities.