Product Approval Information - Licensing Action
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.
Director
Office of Blood Research and Review
Center for Biologics Evaluation and Research