QDJ
- 产品代码
- QDJ
- 器械名称
- Direct-To-Consumer Access Pharmacogenetic Assessment System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.3364
- FDA 专业组
- Medical Genetics
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 3 件
FDA 分类定义
A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users.
FDA 官方分类页： QDJ
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。