SCF

Ldt, Unmet Need Within An Integrated Healthcare System

产品代码: SCF
器械名称: Ldt, Unmet Need Within An Integrated Healthcare System
管理类别: 第 N 类（Not Classified）
FDA 专业组: Unknown
上市路径: Enforcement Discretion

FDA 分类定义

Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).

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： SCF

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。