QFK

Tumor Gene Profiling Test

产品代码: QFK
器械名称: Tumor Gene Profiling Test
管理类别: 第 N 类（Not Classified）
FDA 专业组: Unknown
上市路径: Contact ODE

FDA 分类定义

A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from nucleic acids isolated from human clinical specimens obtained from patients diagnosed with malignant neoplasms using targeted next-generation sequencing.

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： QFK

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。