BD Receives FDA 510(k) Clearance for New Flow Cytometer System with Leucocount Reagent Assay

FRANKLIN LAKES, N.J., April 6, 2017 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration.

When used together with the BD Leucocount^™ kit and BD Trucount^™ tubes, the new BD FACSVia^™ system provides a simple solution for identifying and counting rWBCs in leucoreduced blood products.

"The BD FACSVia system provides blood banks and clinical laboratories with an easy-to-use cell analysis solution to help determine and quantify the presence of residual white blood cells in their blood products," said John Ledek, president of Biosciences for BD. “The addition of the BD FACSVia system follows our larger strategy of making flow cytometry easier to use with improved efficiency, simplified sample analysis and high-quality diagnostic results.”

With an intuitive user interface, the fully automated BD FACSVia system improves overall lab efficiency and simplifies workflow.

The BD FACSVia system offers the performance of a full-function clinical flow cytometer but in a compact design that easily fits on a benchtop or within a hood.