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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.
 
DeviceBREATHTEK UBT FOR H.PYLORI KIT
Generic NameTest, urea adult and pediatric (breath),
Regulation Number866.3110
ApplicantMeridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati, OH 45244
PMA NumberP100025
Supplement NumberS008
Date Received01/13/2015
Decision Date03/05/2015
Withdrawal Date06/16/2025
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 FOR AN AMENDMENT TO THE DRUG MASTER FILE FOR THE FOLLOWING CHANGES: 1) ADDITIONAL PROCESS DEVELOPMENT WORK FOR THE PURIFICATION PROCESS; 2) VALIDATION OF THE PURIFICATION PROCESS IMPROVEMENTS;3) SITE TRANSFER FOR THE PURIFICATION PROCESS; 4) CHANGE TO A SPECIFICATION OF A STARTING MATERIAL; 5. ADDITIONAL SIZES FOR THE OUTER CONTAINER AND INNER BAGS FOR THE PURIFICATION PROCESS; AND 6) UPDATED STABILITY INFORMATION.
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