| 审查小组 | CH |
| 医学专业 | CH |
| 产品代码 | NQL |
| 设备名称 | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| 器械分类等级 | 2 |
| 未分类原因 | |
| GMP豁免 | N |
| 第三方审核 | N |
| 审查代码 | |
| 法规编号 | 862.1055 |
| 提交类型ID | 510(K) |
| 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. |
| 物理状态 | |
| 技术方法 | |
| 目标区域 | |
| 植入式 | N |
| 维护生命设备 | N |