Waters Says BD OneFlow LST Test And BD OneFlow B-CLPD T1 Test Receives FDA 510(k) Clearance For Identifying B-Cell Non-Hodgkin Lymphoma

• BD OneFlow™ LST and BD OneFlow™ B-CLPD T1 Tests now FDA 510(k)-cleared in U.S. for identifying B-cell non-Hodgkin lymphoma (NHL)
• Delivers 96.3% sensitivity and 98.2% specificity1 in identifying chronic lymphocytic leukemia (CLL), one of the most common types of NHL
• All-in-one solution reduces 95% of manual steps,2 delivering workflow efficiency, fast turnaround times, and a reduction in errors

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. This clearance enables commercialization in the U.S. and provides pathologists and clinicians a standardized, ready-to-use flow cytometry testing solution that aids in identification and diagnosis of B-cell non-Hodgkin lymphoma (NHL), including chronic lymphocytic leukemia (CLL), for faster and reliable diagnostic insights.2

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.