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# Grifols Procleix Babesia Assay Approved
- URL: https://www.fdaweb.com/grifols-procleix-babesia-assay-approved/
- Published: 2019-02-07T12:00:00.000Z
- Updated: 2026-09-15T01:01:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143327

FDA has approved a Grifols PMA for the Procleix Babesia assay, a qualitative test for detecting ribosomal RNA from four *Babesia* species (*B. microti, B. duncani, B. divergens, B. venatorum*) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion. *Babesia* is a parasite that can be transmitted to humans by tick bites or through donated blood from *Babesia*\-infected donors. The assay runs on the Procleix Panther system — an automated platform using nucleic acid testing for blood screening.