QMC
- 产品代码
- QMC
- 器械名称
- Transport Medium, Notified Per The Vtm Guidance
- 管理类别
- 第 1 类(Class I)
- 21 CFR 条款
- 21 CFR 866.2390
- FDA 专业组
- Microbiology
- 上市路径
- 需提交 510(k) 上市前通告
FDA 分类定义
Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus).
FDA 官方分类页: QMC
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。