PJI

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

产品代码

PJI

器械名称

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.5930

FDA 专业组

Immunology

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).

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）。