SIO

Test For Esophageal Varices

产品代码

SIO

器械名称

Test For Esophageal Varices

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

A Test for Esophageal Varices is a quantitative test that measures cholate concentrations in human specimens and uses the cholate concentrations to generate a score. The score is used to identify patients unlikely to have large esophageal varices and unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing.

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）。