QMC

Transport Medium, Notified Per The Vtm Guidance

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).

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: 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。