SCJ

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

产品代码: SCJ
器械名称: Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
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) within the scope of the phaseout policy and not subject to a targeted enforcement discretion policy described in section V.B 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： SCJ

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。