PZF

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

产品代码

PZF

器械名称

Mers-Cov And Common Respiratory Pathogens 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)

1 件

FDA 分类定义

A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the detection and identification 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）。