QFO
- 产品代码
- QFO
- 器械名称
- Zika Virus Serological Reagents
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.3935
- 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)
- 4 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.
FDA 官方分类页： QFO
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。