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MEMORANDUM

Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) August 1993

Download the Final Memorandum
Final
Docket Number:
FDA-2013-S-0612
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This memorandum transmits Revised Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments, August, 1993. These revised recommendations modify those issued on April 23, 1992, in regard to testing for anti-HCV. A donor who currently tests, or who in the past had tested, repeatedly reactive for anti-HCV with a solid phase enzyme linked immunoassay (ELISA), licensed by the Food and Drug Administration (FDA), may now be considered for re-entry provided that certain criteria, described in this document, are fulfilled.

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All written comments should be identified with this document's docket number: FDA-2013-S-0612.

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