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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePyloPlus UBT System
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantArj Medical, Inc.
209 State St. E.
Oldsmar, FL 34677
PMA NumberP170022
Supplement NumberS007
Date Received08/05/2025
Decision Date02/05/2026
Product Code OZA 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add the PyloPlus UBT Auto Sampler used with glass breath collection tubes for use with the PyloPlus UBT System using the PyloPlus UBT Lab Analyzer (PPUBTLA -04), and for additions to test kit packaging.
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