QIG
- 产品代码
- QIG
- 器械名称
- Quality Control Material, Genetics, Rna
- 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
RNA quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision or sample concentration and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic RNA controls and cell-line based controls.
FDA 官方分类页： QIG
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。