OAO
- 产品代码
- OAO
- 器械名称
- Cord Blood Processing System And Storage Container
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 864.9900
- FDA 专业组
- Hematology
- 上市路径
- 需提交 510(k) 上市前通告
FDA 分类定义
A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is used as a functionally closed processing system by cord blood establishments. This device includes containers, other soft goods, and centrifugation systems for cord blood product concentration, and a final container for the cryopreservation and the storage of cord blood products.
FDA 官方分类页： OAO
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。