OTA
- 产品代码
- OTA
- 器械名称
- Mass Spectrometer 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）
FDA 分类定义
A mass spectrometer 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 are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature.
FDA 官方分类页： OTA
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。