QUU

Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

产品代码

QUU

器械名称

Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3046

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)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) is a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human clinical samples as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device is simple to use and does not involve sample manipulation or measurement of an analyte that could be affected by conditions such as sample turbidity or cell lysis. This device may be used to aid in the presumptive diagnosis of anthrax in individuals who have signs and symptoms consistent with anthrax and a likelihood of exposure. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, gastrointestinal disease, non-gastrointestinal infections, and an anthrax-like illness caused by B. cereus.

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：2023-11-20。

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。