Procleix Babesia Assay

STN# 125673 Proper Name: Procleix Babesia Assay Tradename: Procleix Babesia Assay Manufacturer: Grifols Diagnostics Solutions Inc. Indication: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens. It is intended for use in screening individual human donors, including donors of whole blood and blood components, and in screening living donors of organ and tissue. It is also intended for use in screening cadaveric (non-heart-beating) donors for B. microti. It is not intended for use on cord blood specimens. Lysed individual donor whole blood samples are tested either individually or in pools of equal aliquots of not more than 16. Cadaveric donor specimens must be tested individually and not pooled. This assay is not intended for use as an aid in diagnosis of Babesia infection. Product Information Package Insert - Procleix Babesia Assay Supporting Documents December 16, 2025 Approval Letter - Procleix Babesia Assay November 20, 2020 Approval Letter - Procleix Babesia Assay February 12, 2020 Approval Letter - Procleix Babesia Assay January 24, 2019 Approval Letter – Procleix Babesia Assay January 18, 2019 Summary Basis of Regulatory Action - Procleix Babesia Assay