Waters achieves US FDA 510(k) clearance for ready-to-use flow cytometry clinical tests for Leukemia and Lymphoma
India, Nov. 11 -- Waters Corporation has announced that the BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test have received US Food and Drug Administration (FDA) 510(k) clearance. This clearance enables commercialisation in the US and provides pathologists and clinicians a standardised, 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.
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, a...
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