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Vaccines, Blood & Biologics

September 18, 2001 Companion Approval Letter for Source Plasma - UltraQual HCV RT-PCR Assay

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

September 18, 2001

Our STN: BL 102482/1298

Mr. J. Claude Miller
Senior Vice President
Quality and Regulatory Compliance
Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, California 90032

Dear Mr. Miller:

Your request to supplement your Biologics License Application (BLA) for human Source Plasma to include the National Genetics Institute UltraQual Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay (UltraQual HCV RT-PCR Assay), when used in combination with FDA approved pooling and resolution algorithms, as indicated for the qualitative detection of hepatitis C virus (HCV) ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples, has been approved. The UltraQual HCV RT-PCR Assay will be performed at National Genetics Institute, 2440 S. Sepulveda Boulevard #130, Los Angeles, California 90064.

This information has been placed in your biologics license file. Please keep a copy of this letter available for review at the time of FDA inspections.

Sincerely yours,

--- signature ---

Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research

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