NRS
- 产品代码
- NRS
- 器械名称
- Control Material, Blood Circulating Epithelial Cancer Cell
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 864.8625
- FDA 专业组
- Hematology
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
- 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
The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.
FDA 官方分类页： NRS
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。