SCU

Dna And Rna Oncology Controls

产品代码: SCU
器械名称: Dna And Rna Oncology Controls
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 866.5910
FDA 专业组: Microbiology
上市路径: 豁免 510(k)（仍须遵守通用控制与注册列名）

FDA 分类定义

Oncology controls are a device intended for use in a next generation sequencing (NGS)-based in vitro diagnostic test system as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of the workflow by detecting systematic analytical deviations that may arise from reagent or instrument variation. This type of device includes synthetic DNA and RNA controls.

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： SCU

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。