SGD

Kit D816v Mutation Detection System

产品代码: SGD
器械名称: Kit D816v Mutation Detection System
管理类别: 第 F 类（HDE）
FDA 专业组: Unknown
上市路径: HDE - Humanitarian Device Exemption

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

FDA 官方分类页： SGD

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。