PKB

Autosomal Recessive Carrier Screening Gene Mutation Detection System

产品代码

PKB

器械名称

Autosomal Recessive Carrier Screening Gene Mutation Detection System

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.5940

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)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.

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）。