Proper Name: Procleix Zika Virus Assay
Manufacturer: Grifols Diagnostic Solutions, Inc.
- 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.