QID

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

产品代码

QID

器械名称

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.4002

FDA 专业组

Microbiology

上市路径

需提交 510(k) 上市前通告

标记

属生命支持/维持器械

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 device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure.  Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.

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）。