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
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
November 21, 2007
April 23, 2024
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