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Vaccines, Blood & Biologics

March 9, 2005 Approval Letter - COBAS AmpliScreen HIV-1 Test

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

March 9, 2005

Our STN: BLA 125059-13

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

Dear Ms. Long:

Your request to supplement your Biologics License Application (BLA) for Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction) to allow for an expanded intended use claim to include testing of individual cadaveric specimens (obtained from non-heart-beating donors), 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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