Waters Achieves FDA 510(k) Clearance for Ready-to-Use Flow Cytometry Clinical Tests for Leukemia and Lymphoma

MILFORD, Mass., Nov. 10, 2026 /PRNewswire/ -- Waters Corporation (NYSE: WAT) today announced that the BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test have received U.S. Food and Drug Administration (FDA) 510(k) clearance.

The latest in a series of innovations delivered since Waters combined with BD’s Biosciences & Diagnostic Solutions Businesses, the BD OneFlow Solution integrates reagents, instruments, defined staining protocols, pre-defined assay templates, and supporting consumables into a consistent, recurring workflow for immunophenotyping normal and abnormal cell populations. The solution significantly reduces hands-on time compared to liquid reagent cocktails, helping labs increase workflow efficiency, speed turnaround time, and lower the risk of human error.

Sign up for Blog Updates