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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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August 2, 2005 Approval Letter - COBAS AmpliScreen HBV

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

August 2, 2005

Our STN: BL125090/3

Roche Molecular Systems, Inc.
Attention: Thomas S. Clement
Senior Director, Regulatory Affairs
4300 Hacienda Drive
PO Box 9002
Pleasanton, California 94566-0900

Dear Mr. Clement:

Your request to supplement your Biologics License Application (BLA) for Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) to allow for an expanded claim to include testing for Hepatitis B Virus DNA in post-mortem cadaveric (non-heart-beating) donors using an individual testing format, has 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

 

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