STN: BL 125121
Proper Name: West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
Tradename: PROCLEIX WNV ASSAY
Manufacturer: Grifols Diagnostic Solutions Inc.
Indications:

• The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including donors of whole blood, blood components & other living donors.

Product Information

• Package Insert - PROCLEIX WNV ASSAY

Supporting Documents

• January 22, 2020 Approval Letter - PROCLEIX WNV ASSAY
• May 25, 2018 Summary Basis for Regulatory Action - Procleix WNV Assay
• May 25, 2018 Approval Letter - Procleix West Nile Virus Assay
• Supporting Documents older than three years - Procleix West Nile Virus (WNV) Assay