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Medical Devices / Submissions and Approvals

BD Gains FDA Clearance For New Flow Cytometer System with Leucocount Reagent Assay

April 7, 2017

BD (Becton, Dickinson and Company) has gained FDA marketing clearance for its flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration.

When the BD FACSVia system is used in conjunction with the BD Leucocount kit and BD Trucount tubes, it identifies and counts residual white blood cells in leucoreduced blood products.

The device operates like a full-function clinical flow cytometer but in a compact design that fits on a benchtop. — Cynthia Jessup

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