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Medical Devices / Submissions and Approvals

FDA Approves Grifols’ Babesia Test

Feb. 12, 2019
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The FDA approved Grifols’ Procleix Babesia assay for use on the company’s Procleix Panther system, a fully automated blood screener for use by blood banks.

The Spanish devicemaker’s assay detects ribosomal RNA from four Babesia species — B. microti, B. duncani, B. divergens and B. venatorum. Babesia is a malaria-likeparasite that can infect red blood cells.

The approval was based on a successful multi-center clinical trial by the American Red Cross, Creative Testing Solutions, and the Rhode Island Blood Center.

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