The definition of in vitro diagnostic reagents for blood-borne screening 血源性筛查的体外诊断试剂定义

In accordance with the Health Document “Notice on the Implementation of Batch National Verification of In Vitro Immunodiagnostic Agents for Blood Samples for Blood Donors” (Weifa 1994 No. 10), Notice on the Issue of Targeted Production of Anti-A and Anti-B Blood Type Sterilization Reagents 》(Wei Medicine 1995 No. 26) There are five types of national statutory screening for blood sources:

         1, A, B, O blood type styling reagents;

         2. Hepatitis B surface antigen enzyme-linked immunoassay reagent;

         3, hepatitis C virus antibody enzyme immunoassay reagents;

         4. HIV antibody-enzyme immunoassay reagent

         5, Syphilis diagnostic reagents.