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January 16, 2004 Corrected Letter - COBAS AmpliScreen HIV-1 Test

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

January 16, 2004

Our STN: BLA 125059/6

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

Dear Mr. Riordan:

In our approval letter dated December 19, 2003, the approved intended use was incorrectly stated.

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 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

Please correct your files accordingly.

Sincerely yours,


--- signature ---


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