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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 (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantMeridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati, OH 45244
PMA NumberP100025
Supplement NumberS004
Date Received02/01/2013
Decision Date05/29/2013
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE LABELING FOR THE BREATHTEK® UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0, INCLUDING THE PACKAGE INSERT AND HOW TO GUIDE.
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