SIO

Test For Esophageal Varices

Product code

SIO

Device name

Test For Esophageal Varices

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).