QMV

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

产品代码

QMV

器械名称

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3966

FDA 专业组

Microbiology

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

其中 Summary 已存档

1 份，可直接下载

FDA 历史累计 510(k)

3 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.

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：2024-12-05。

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。