QQB
- 产品代码
- QQB
- 器械名称
- Prognostic Test For Assessment Of Liver Related Disease Progression
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.1622
- FDA 专业组
- Clinical Chemistry
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses.
FDA 官方分类页： QQB
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。