Singapore, June 4 -- Waters Corporation has announced that the BD BACTEC FXI Culture System has received US Food and Drug Administration (FDA) 510(k) clearance. This clearance enables commercialisation in the US and provides a new option for laboratories seeking a fully automated blood culture system designed to improve the speed, consistency, and accuracy of sepsis and bloodstream infection diagnostics in modern microbiology laboratories.

The BD BACTEC FXI Culture System features a first-of-its-kind capability in a blood culture platform - an automated gravimetric measurement of individual blood culture vial volume. By objectively confirming blood volume in each vial, the system reduces pre-analytical variability and supports more consi...