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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 2, 2007 Approval Letter - Procleix WNV Assay

March 2, 2007

Our STN: BL 125121/17

Gen-Probe Incorporated
Attn: Leanne M. Kiviharju
10210 Genetic Center Drive
San Diego, CA 92121

Dear Ms. Kiviharju:

We have approved your request to supplement your biologics license application for your Procleix West Nile Virus (WNV) Assay, to allow revised labeling and supporting information for performing the Procleix WNV Assay with the Procleix TIGRIS System.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,


Jay S. Epstein, M.D.
Office of Blood Research and Review


Contact FDA

(800) 835-4709
(240) 402-8010
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Food and Drug Administration

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