PROCLEIX WNV ASSAY
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 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, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.
- The assay is intended for use in testing individual donor samples. It is also intended for use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood components.
- This assay is not intended for use as an aid in the diagnosis of West Nile Virus infection.
Product Information
Supporting Documents
- October 8, 2024 Approval Letter - PROCLEIX WNV ASSAY
- November 20, 2020 Approval Letter - PROCLEIX WNV ASSAY
- January 22, 2020 Approval Letter - PROCLEIX WNV ASSAY
- May 25, 2018 Approval Letter - Procleix West Nile Virus Assay
- May 25, 2018 Summary Basis for Regulatory Action - Procleix WNV Assay
- Supporting Documents older than three years - Procleix West Nile Virus (WNV) Assay