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News 2017-06-11T10:47:16+00:00

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Disclaimer: In the US, the BreathID® Hp System and the BreathID® Hp Lab System are intended for use in the qualitative detection of H. pylori. They have FDA 510(k) clearance and an approved NDA for the 13C-urea tablet and Citrica powder. Other applications are limited in the US by Federal Law to investigational use only. In Europe, BreathID® devices have CE approval for diagnostic monitoring of the digestive system and liver. In China and additional countries, the BreathID® Hp device is approved for the detection of H. pylori