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GUIDANCE DOCUMENT

Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes Guidance for Industry November 2007

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2002-D-0175
Issued by:
Guidance Issuing Office
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.

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All written comments should be identified with this document's docket number: FDA-2002-D-0175.

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