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.

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Procleix Babesia Assay

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