SGD

Kit D816v Mutation Detection System

Product code: SGD
Device name: Kit D816v Mutation Detection System
Device class: Class F
Medical specialty: Unknown
Marketing pathway: HDE - Humanitarian Device Exemption

FDA classification definition

A KIT D816V mutation detection system is an in vitro diagnostic test intended for qualitative detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis using nucleic acid amplification and real time detection systems. The KIT D816V mutation detection system is indicated as an aid in the selection of aggressive systemic mastocytosis patients for whom Gleevec® (imatinib mesylate) treatment is being considered.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SGD

Classification and pathway per current FDA publications. Data from openFDA (CC0).