QAZ

Cancer Predisposition Risk Assessment System

产品代码

QAZ

器械名称

Cancer Predisposition Risk Assessment System

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.6090

FDA 专业组

Medical Genetics

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

4 件

FDA 分类定义

A qualitative in vitro molecular diagnostic system used for the detection of select variants in specified cancer-related genes. The device is intended to be used on genomic DNA isolated from human specimens collected by the user. The results of the test provide users with a genetic health risk assessment for developing certain cancers. The test may not include all variants associated with a predisposition of developing cancer and is not intended to describe a person’s overall risk of developing any type of cancer nor to aid in determination of treatment or act as a substitute for recommended cancer screenings or appropriate follow-up. The device is for over-the-counter use.

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）。