QMN
- 产品代码
- QMN
- 器械名称
- Covid-19 Multi-Analyte Antigen Device
- 管理类别
- 第 N 类（Not Classified）
- FDA 专业组
- Unknown
- 上市路径
- EUA - Emergency Use Authorization
FDA 分类定义
A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information.
FDA 官方分类页： QMN
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。