About This File
- Docket Number: 2002D-0081
- Issued by: Center for Biologics Evaluation and Research
Blood establishments are required under 21 CFR 610.40(a)(3) and (b) to test donations of human blood and blood components for hepatitis B virus using approved screening tests that are adequate and appropriate for this purpose. One test used to detect the presence of hepatitis B infection is the hepatitis B surface antigen (HBsAg) test.