Procleix Zika Virus Assay
STN# 125667
Proper Name: Procleix Zika Virus Assay
Tradename: Procleix Zika Virus Assay
Manufacturer: Grifols Diagnostic Solutions, Inc.
Indication:
- The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid test for the detection of Zika virus (ZIKV) RNA in plasma specimens from individual human donors, including donors of whole blood and blood components for transfusion.
Product Information
Supporting Documents
- November 20, 2020 Approval Letter - Procleix Zika Virus Assay
- July 5, 2018 Approval Letter - Procleix Zika Virus Assay
- July 2, 2018 Summary Basis for Regulatory Action - Procleix Zika Virus Assay