QLF
- 产品代码
- QLF
- 器械名称
- On-Body Injector
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5860
- FDA 专业组
- General Hospital
- 上市路径
- Contact ODE
FDA 分类定义
An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for the infusion of drugs.
FDA 官方分类页： QLF
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。