Waters Announces FDA 510(k) Clearance of BD BACTEC FXI Culture System, Enabling Broader Access to Bloodstream Infection Diagnostics

FDA 510(k)-cleared BD BACTEC™ FXI Culture System now available to U.S. market, enabling broader access to confident bloodstream infection diagnostics. Achieves a 3-hour faster time to detection (~15% reduction) versus the prior-generation system, per clinical study data, enabling earlier targeted sepsis prevention.