Disclaimer:
In the
USA,
The BreathID System is intended for use in the qualitative detection of H. pylori. It has an approved 510(K) and an approved NDA for the
13
C-urea Tablet and Citrica Powder
. Other applications are limited by Federal (of United States) Law to Investigational
Use only.
In Europe: The BreathID System has a CE approval for assessing Helicobacter pylori, Liver Function, and Gastric Emptying Rate.