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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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May 13, 2004 Approval Letter - COBAS AmpliScreen HCV Test

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

May 13, 2004

Our STN: BLA 125045-5011

Ms. Karen Long
Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900

Dear Ms. Long:

Your request to supplement your Biologics License Application (BLA) for Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) to allow for an expanded intended use claim to include testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing, has been approved.

Your request for additional indications for testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) has also been approved.

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 ---

Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research