QIC
- 产品代码
- QIC
- 器械名称
- Hiv-1 Genotyping Assay Using Ngs Technology
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.3955
- FDA 专业组
- Medical Genetics
- 上市路径
- 需提交 510(k) 上市前通告
FDA 分类定义
The human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology is a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection.
FDA 官方分类页： QIC
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。