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Guidance on Requalifying Blood Donors

05/21/2008

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti- HBc). It provides recommendations to establishments that collect human blood or blood components for a requalification method or process to reenter deferred donors into a donor pool based on a determination that the previous tests that were repeatedly reactive for anti-HBc were falsely positive and that there is no evidence of infection with Hepatitis B virus. To download this guidance, click here. To view this notice, click here.

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