Waters Corp. Gets FDA Clearance For BD BACTEC FXI Culture System

(RTTNews) - Waters Corporation (WAT) on Wednesday said the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration 510(k) clearance.

The BD BACTEC FXI Culture System is a next-generation, fully automated blood culture system designed to improve the speed, consistency, and accuracy of bloodstream infection diagnostics.

The company said the system automates vial loading, unloading, incubation, and detection alerts, and can load up to 60 vials at a time, 50% more than the leading competing system. Clinical study data showed that the BD BACTEC FXI Culture System reduced the mean time to detection by about three hours compared with the previous-generation BD BACTEC FX Blood Culture System.

Waters Corp. shares closed at $371.93 on Tuesday, down 1.65%