QJX
- 产品代码
- QJX
- 器械名称
- Caries Detection Product With Drug Or Biologic
- 管理类别
- 第 3 类(Class III)
- FDA 专业组
- Unknown
- 上市路径
- 需 PMA 上市前批准
FDA 分类定义
Intended to aid in the detection of tooth decay by measuring increased visible light, fluorescence, or luminescence induced by caries-activated drug or biologic.
FDA 官方分类页: QJX
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。