QOF

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

产品代码

QOF

器械名称

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3981

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)

25 件

其中 Summary 已存档

21 份，可直接下载

FDA 历史累计 510(k)

33 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 nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data 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)（25 件）

数据窗口为最近三年。最新一件：2026-06-12。

其中 21 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。