NXD

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

产品代码

NXD

器械名称

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3332

FDA 专业组

Microbiology

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

3 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza a viruses and provide epidemiological information on influenza. These reagents are primers and probes, along with a specific novel influenza virus control.

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）。