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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 22, 2004 Approval Letter

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

July 22, 2004

Submission Tracking Number (STN): BL 103385/5004

Matthew E. Klamrzynski
Abbott Laboratories
D-049C/AP6C/2
100 Abbott Park Road
Abbott Park, IL 60064-3500

Dear Mr. Klamrzynski:

Your request to supplement your Biologics License Application for Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA)/Recombinant)to allow a labeling change for the Abbott HIVAB HIV-1/HIV-2 (rDNA) EIA, to extend the indications for use to include cadaveric serum specimen testing., 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