NHG
- 产品代码
- NHG
- 器械名称
- Enzyme Immunoassay, Cortisol, Salivary
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.1205
- FDA 专业组
- Clinical Chemistry
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 7 件
FDA 分类定义
The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.
FDA 官方分类页： NHG
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。