PFT
- 产品代码
- PFT
- 器械名称
- Reagents For Molecular Diagnostic Test Systems
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 862.3800
- FDA 专业组
- Clinical Chemistry
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
- 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 kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems.
FDA 官方分类页： PFT
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。