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FDA Guidance for Industry: 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

Origin/Publisher:

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078800.pdf

Document Type:
Guidance for Industry
Content:
This document provides recommendations to manufacturers of HBsAg assays that are intended to be used to test donors of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and to establishments using an HBsAg assay.

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