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Disclaimer: In the USA, the BreathID System is intended for use in the qualitative detection of H. pylori. It has FDA 510(k)
clearance and an approved NDA for the 13C-urea tablet and citrica powder.
Other applications are limited in the U.S. by U.S. federal law to Investigational Use only. In Europe, the BreathID and BreathID Hp devices have CE approval for diagnostic monitoring of the digestive system and liver.