Beijing Wantai Biological Pharmacy Enterprise (603392.SH): Obtained Medical Device Registration Certificate for HIV Antibody Oral Mucosal Transudate Self-Test Kit.

date
16:07 25/12/2025
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GMT Eight
Wan Tai Biology (603392.SH) announced that recently, the company's independently developed human immunodeficiency virus (HIV 1+2) antibody oral mucosal exudate test kit (colloidal gold method) has obtained the "Medical Device Registration Certificate (In Vitro Diagnostic Reagent) of the People's Republic of China" issued by the National Medical Products Administration.
Beijing Wantai Biological Pharmacy Enterprise (603392.SH) announced that the self-developed Human Immunodeficiency Virus (HIV1+2) antibody oral mucosal exudate test kit (colloidal gold method) has been granted the "Medical Device Registration Certificate of the People's Republic of China (In vitro Diagnostic Reagent)" by the National Medical Products Administration. This product is the first domestically approved test kit for self-testing HIV antibody in oral mucosal exudate. Following the Human Immunodeficiency Virus 1 Type Urine Antibody Test Kit (colloidal gold method) and Human Immunodeficiency Virus (HIV1+2) antibody test kit (colloidal gold method), this is another approved HIV test kit that can be used by consumers for self-testing. The upgraded version of the urine self-test kit for human immunodeficiency virus 1+2 type antibody urine test kit (colloidal gold method) has also been simultaneously approved. This marks the company's leading position and innovative capabilities in the field of self-testing for HIV, once again receiving recognition from the national authorities.