QRV
- 产品代码
- QRV
- 器械名称
- Setmelanotide Eligibility Gene Variant Detection System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.1164
- FDA 专业组
- Clinical Chemistry
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
A setmelanotide eligibility gene variant detection system is a qualitative in vitro diagnostic device intended to detect germline variants within genes isolated from human specimens for the purpose of identifying patients with obesity who may benefit from treatment with setmelanotide in accordance with the approved therapeutic product labeling.
FDA 官方分类页： QRV
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。