NQL

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

产品代码

NQL

器械名称

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 862.1055

FDA 专业组

Clinical Chemistry

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

5 件

FDA 分类定义

Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.

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）。