Procleix Plasmodium Assay
STN# 125862
Proper Name: Procleix Plasmodium Assay
Tradename: Procleix Plasmodium Assay
Manufacturer: Grifols Diagnostics Solutions Inc.
Indication:
- The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Plasmodium species (P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) 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 not intended for use on cord blood specimens. Lysed whole blood donor samples are tested individually.
- The test is not intended for use as an aid in diagnosis of Plasmodium infection.
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