QNC
- 产品代码
- QNC
- 器械名称
- Whole Exome Sequencing Constituent Device
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.6000
- FDA 专业组
- Medical Genetics
- 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
A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device.
FDA 官方分类页： QNC
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。