OZA
- 产品代码
- OZA
- 器械名称
- Test, Urea Adult And Pediatric (Breath),
- 管理类别
- 第 3 类（Class III）
- 21 CFR 条款
- 21 CFR 866.3110
- FDA 专业组
- Microbiology
- 上市路径
- 需 PMA 上市前批准
FDA 分类定义
Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy.
FDA 官方分类页： OZA
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。