NSU
- 产品代码
- NSU
- 器械名称
- Instrumentation For Clinical Multiplex Test Systems
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.2570
- 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）
- 该代码近三年的 510(k)
- 13 件
FDA 分类定义
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de
FDA 官方分类页： NSU
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。