Product Approval Information
Proper Name: West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
Tradename: Procleix West Nile Virus (WNV) Assay
Manufacturer: Gen-Probe, Inc, License #1592
Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.
Date: March 2, 2007
Revised labeling: To perform the Procleix WNV Assay with the Procleix TIGRIS System
March 2, 2007 Approval Letter
FDA Approves First Fully Automated Test to Screen for West Nile Virus in Blood and Tissue Donors - March 2, 2007
Date: December 1, 2005
Indication: Qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors; testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.
December 1, 2005 Approval Letter
FDA Approves First Test to Screen for West Nile Virus in Donors of Blood, Organs, Cells and Tissues - December 1, 2005
Summary Basis of Approval (PDF - 147 KB)