OZF
- 产品代码
- OZF
- 器械名称
- Tissue Rna Preservative For Collection, Storage, And Transportation
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 866.4070
- FDA 专业组
- Immunology
- 上市路径
- 需提交 510(k) 上市前通告
- 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 human tissue RNA preservation collection, storage, and transportation tube is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and further molecular diagnostic testing.
FDA 官方分类页: OZF
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。