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PyloPlus+ Urea Breath Test Analyzer

Details

Device typeInfrared spectrometry breath analyser IVD: An electrically-powered laboratory or point-of-care instrument designed to use infrared spectrometry technology for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a specimen of air exhaled from a patient. It is typically used to measure analytes such as ingested carbon isotopes that have been metabolized (e.g., 13C, 14C) to establish a correlation with metabolic profiles or disorders [e.g., gastrointestinal H. pylori infection]. The device operates with minimal technician involvement and complete automation of all procedural steps.

FDA categoryTest, Urea Adult And Pediatric (Breath),

Device ID00860001810363

MRI safetyLabeling does not contain MRI Safety Information

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