MWA

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

产品代码

MWA

器械名称

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3372

FDA 专业组

Microbiology

上市路径

需提交 510(k) 上市前通告

FDA 分类定义

intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other 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）。