NHY
- 产品代码
- NHY
- 器械名称
- Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 866.3480
- FDA 专业组
- Microbiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
FDA 分类定义
These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.
FDA 官方分类页： NHY
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。