QLT

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

产品代码

QLT

器械名称

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

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

Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, 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 used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。