OHQ

Multi-Analyte Controls Unassayed

产品代码

OHQ

器械名称

Multi-Analyte Controls Unassayed

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 862.1660

FDA 专业组

Clinical Chemistry

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

A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis 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）。