QWZ
- 产品代码
- QWZ
- 器械名称
- Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.1223
- 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)
- 1 件
FDA 分类定义
A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product.
FDA 官方分类页： QWZ
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。