OEO
- 产品代码
- OEO
- 器械名称
- Automated Digital Image Manual Interpretation Microscope
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 864.1860
- FDA 专业组
- Hematology
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 6 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor. Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer.
FDA 官方分类页： OEO
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。