QWR

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

产品代码

QWR

器械名称

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3982

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)

2 件

其中 Summary 已存档

2 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 simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.

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)（2 件）

数据窗口为最近三年。最新一件：2025-04-11。

其中 2 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。