Product Approval Information

Proper Name: West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
Tradename: cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system
Manufacturer: Roche Molecular Systems, Inc, License #1636

Package Insert (PDF - 375 KB) - Approved: April 2, 2008

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Date: April 2, 2008
Indication: To include testing for West Nile Virus RNA in post mortem cadaveric (non-heart-beating) donors using an individual testing format
April 2, 2008 Approval Letter

Date: August 28, 2007
Indication: For the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating.
August 28, 2007 Approval Letter
FDA Approves Second West Nile Virus Screening Test for Donated Blood and Organs
Summary Basis for Approval (PDF 177KB) - August, 2007