BD Receives FDA 510(K) Clearance for Molecular Test of Acute Gastroenteritis.

BD (Becton, Dickinson and Company), a global medical technology company, announced 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for its newly developed molecular test. This test will help detect harmful intestinal bacteria causing infectious diarrhea.

According to the Centers for Disease Control and Prevention (CDC), one out of every six American suffers from infection due to food-borne illness each year. BD MAX extended enteric bacterial panel has come as a relief for patients suffering from acute gastroenteritis, an inflammation of the gastrointestinal tract leading to hospitalization.

This panel along with the BD MAX enteric bacterial panel and the BD MAX enteric parasite panel, aims to enable individualized testing that can be be performed based on a patient's symptoms and health history.

Doug White, vice president and general manager of Molecular Diagnostics and Women's Health for BD said, "We continue to expand the BD MAX system menu of unique, clinically relevant panels. The BD MAX system allows the diagnostic laboratory to perform molecular testing in a flexible, automated manner, enabling timely results and more efficient patient manage­ment."