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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.
 
DeviceBREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantMeridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati, OH 45244
PMA NumberP100025
Supplement NumberS010
Date Received09/15/2015
Decision Date01/27/2016
Withdrawal Date06/16/2025
Product Code OZA 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND THE HOW TO GUIDE FOR THE BREATHTEK® UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA).
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