QYC

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

产品代码
QYC
器械名称
Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 864.9115
FDA 专业组
Hematology
上市路径
需提交 510(k) 上市前通告

FDA 分类定义

The container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

FDA 官方分类页: QYC
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。