Vaccines, Blood & Biologics
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Procleix West Nile Virus (WNV) Assay
STN: BL 125121/17
Proper Name: West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
Tradename: Procleix West Nile Virus (WNV) Assay
Manufacturer: Gen-Probe, Inc, License #1592
Indications:
- For the 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
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Supporting Documents
March 2, 2007 Approval Letter - Procleix WNV Assay
Revised labeling: To perform the Procleix WNV Assay with the Procleix TIGRIS SystemDecember 1, 2005 Approval Letter - Procleix WNV Assay
Indication: For the 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.West Nile Virus - Procleix WNV Assay - Summary basis of Approval (PDF - 148KB)
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Related Information
FDA Online Label Repository
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