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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 19, 2003 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

December 19, 2003

Our STN: BLA 125059/6

Mr. Gary Riordan
Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900

Dear Mr. Riordan:

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 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 an additional indication for testing plasma samples from living organ donors 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

Link to corrected letter