QIV

Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

产品代码

QIV

器械名称

Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.1655

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)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection.

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）。