PGE
- 产品代码
- PGE
- 器械名称
- Gastric Emptying Breath Test
- 管理类别
- 第 3 类（Class III）
- FDA 专业组
- Unknown
- 上市路径
- 需 PMA 上市前批准
FDA 分类定义
Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal.
FDA 官方分类页： PGE
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。