PFX

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

产品代码

PFX

器械名称

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.5920

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)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods. It is intended as an aid in the postnatal diagnosis of developmental delay and/or intellectual disability (DD/ID), congenital anomalies, and dysmorphic features in conjunction with other clinical information currently used in postnatal diagnosis. It is not intended to be used for standalone diagnostic purposes, prenatal or pre-implantation testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations.

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）。