QDP
- 产品代码
- QDP
- 器械名称
- Respiratory Panel
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.3985
- 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)
- 2 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
The panel is a multiplexed nucleic acid test intended for use with systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection.
FDA 官方分类页： QDP
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。