OEP
- 产品代码
- OEP
- 器械名称
- Influenza A Virus Subtype Differentiation Nucleic Acid Assay
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.3980
- 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
A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.
FDA 官方分类页： OEP
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。