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  1. Vaccines, Blood & Biologics

Procleix Zika Virus Assay

STN# 125667
Proper Name: Procleix Zika Virus Assay
Tradename: None
Manufacturer: Grifols Diagnostic Solutions, Inc.

Indication:

  • Intended for the detection of Zika virus (ZIKV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, for transfusion.
  • It is also intended for use in testing plasma or serum specimens to screen other living (heart-beating) donors of organs and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), and in testing blood specimens to screen cadaveric (non-heart-beating) donors.
  • The assay is intended for use in testing individual donor samples.
  • It is also intended for use in testing pools of human plasma composed of equal aliquots of not more than 16 individual specimens from volunteer donors of whole blood components.
     

Product Information

Supporting Documents