PVQ
- 产品代码
- PVQ
- 器械名称
- Rickettsia Spp. Nucleic Acid Based Detection Assay
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.3316
- 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
An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.
FDA 官方分类页： PVQ
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。