OMS
- 产品代码
- OMS
- 器械名称
- Novel Influenza A Virus, A/H5 Ns1 Protein
- 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)
- 1 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 to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein 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.
FDA 官方分类页： OMS
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。