PMA P100025S008

Device: BREATHTEK UBT FOR H.PYLORI KIT
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S008
Product code: OZA
Decision date: 2015-03-05
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
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.

Current openFDA PMA Record#

Device: BREATHTEK UBT FOR H.PYLORI KIT
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S008
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2015-03-05
Decision code: APPR
Date received: 2015-01-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.