NIA

Assay, Direct, Nucleic Acid Amplification, Influenza Virus

产品代码: NIA
器械名称: Assay, Direct, Nucleic Acid Amplification, Influenza Virus
管理类别: 第 1 类（Class I）
21 CFR 条款: 21 CFR 866.3330
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 Influenza 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.

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）。

FDA 官方分类页： NIA

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。