NOE
- 产品代码
- NOE
- 器械名称
- Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.5600
- 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)
- 8 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein.
FDA 官方分类页： NOE
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。