OTG

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

产品代码: OTG
器械名称: Non-Sars Coronavirus Multiplex Nucleic Acid Assay
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 866.3980
FDA 专业组: Microbiology
上市路径: 需提交 510(k) 上市前通告

FDA 分类定义

A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human non-SARS coronavirus nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract non-SARS coronavirus infections if used in conjunction with other clinical and laboratory findings.

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）。

FDA 官方分类页： OTG

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。