PEU
- 产品代码
- PEU
- 器械名称
- System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 866.3373
- FDA 专业组
- Microbiology
- 上市路径
- 需提交 510(k) 上市前通告
- 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
The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
FDA 官方分类页： PEU
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。