QDS

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

产品代码: QDS
器械名称: Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 866.4001
FDA 专业组: Pathology
上市路径: 需提交 510(k) 上市前通告
该代码近三年的 510(k): 3 件

FDA 分类定义

A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities.

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）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2024-11-06。

510(k) 号	批准日期	申请人	器械名称	摘要
K243222	2024-11-06	Biofire Diagnostics, LLC (Biomerieux)	BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumon	PDF

其中 1 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。

FDA 官方分类页： QDS

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。