PRB
- 产品代码
- PRB
- 器械名称
- Cervical Intraepithelial Neoplasia (Cin) Test System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 864.1865
- FDA 专业组
- Pathology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 2 件
FDA 分类定义
The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.
FDA 官方分类页： PRB
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。