Roche, Wondfo, BGI Genereal, Acon Among Five IVD Products Granted Market Approval
Roche
Oncology Drug Research, Development, and Manufacturing
Approved Products
On March 25, the editor compiled the information released by the National Medical Products Administration,5 ModelsIVD Product Approved, Details as Follows:
Roche Diagnostics Products (Shanghai) Co., Ltd.
Product Name:Free Thyroxine Assay Kit (Electrochemiluminescence Method)
Certificate No.:China Medical Device Registration No. 20242400152
Date:2024-03-25
Shenzhen Aikang Reagent Co., Ltd.
Product Name:Hepatitis B Virus Surface Antigen Diagnostic Kit (Colloidal Gold Method)
Certificate No.:China Medical Device Registration Certificate 20243400578
Date:2024-03-25
Shenzhen Aikang Reagent Co., Ltd.
Product Name:Treponema Pallidum Antibody Detection Kit (Colloidal Gold Method)
Certificate No.:China Medical Device Registration Certificate 20243400580
Date:2024-03-25
Guangzhou Wondfo Biotech Co., Ltd.
Product Name:Abnormal Prothrombin Detection Kit (Chemiluminescence Immunoassay)
Certificate No.:China Medical Device Registration Certificate 20243400583
Date:2024-03-25
Beijing Huada Than Bi Love Biotechnology Co., Ltd.
Product Name:Human Immunodeficiency Virus Antigen/Antibody Detection Kit (Magnetic Particle Chemiluminescence Method)
Certificate No.:China Medical Device Registration Certificate 20243400577
Date:2024-03-25
