OOU

Parainfluenza Multiplex Nucleic Acid Assay

产品代码

OOU

器械名称

Parainfluenza Multiplex Nucleic Acid Assay

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3980

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)

5 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.

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）。