NUA

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

产品代码

NUA

器械名称

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.5900

FDA 专业组

Immunology

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

12 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.

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）。