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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DevicePyloPlus UBT System
Generic Nametest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantARJ Medical Inc.
209 state street e
oldsmar, FL 34677
PMA NumberP170022
Date Received07/26/2017
Decision Date02/18/2020
Product Code OZA 
Docket Number 20M-0985
Notice Date 02/26/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of the PyloPlus UBT.The PyloPlus UBT system is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis of H. pylori infection in adults 18 years old and older. The PyloPlus UBT system consists of the PyloPlus UBT Kit and the PyloPlus UBT analyzer. The analyzer is an infrared Spectrometer used for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. The PyloPlus UBT system is for use by trained health care professionals as prescribed by a physician.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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