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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 103356/5000

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 Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant) to allow a labeling change 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

 

Return to the Abbott HCV EIA 2.0 page

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448