PMA P100025S007

Device: BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S007
Product code: OZA
Decision date: 2015-02-03
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: APPROVAL FOR CAMBRIDGE ISOTOPE LABORATORIES, INC. (CIL'S) AMENDED DRUG MASTER FILE (DMF) #11378 ON BEHALF OF OAPI'S PMA APPLICATION WHICH USES THE DRUG AS A COMPONENT OF THE BREATHTEK UBT FOR H. PYLORI KIT. THIS SUPPLEMENT REQUESTS THE REVIEW OF THE FOLLOWING CHANGES TO THE DRUG MASTER FILE:1. PROCESS CHANGE TO MANUFACTURING SCALE TO ADD 18KG PROCESS;2. UPDATE TO SPECIFICATIONS AND TEST METHODS FOR 13C-UREA;3. CHANGES IN QC TESTING LOCATIONS; AND 4. CHANGES IN MANUFACTURING LOCATIONS FOR 18KG PROCESS.

Current openFDA PMA Record#

Device: BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S007
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2015-02-03
Decision code: APPR
Date received: 2014-08-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CAMBRIDGE ISOTOPE LABORATORIES, INC. (CIL'S) AMENDED DRUG MASTER FILE (DMF) #11378 ON BEHALF OF OAPI'S PMA APPLICATION WHICH USES THE DRUG AS A COMPONENT OF THE BREATHTEK UBT FOR H. PYLORI KIT. THIS SUPPLEMENT REQUESTS THE REVIEW OF THE FOLLOWING CHANGES TO THE DRUG MASTER FILE:1. PROCESS CHANGE TO MANUFACTURING SCALE TO ADD 18KG PROCESS;2. UPDATE TO SPECIFICATIONS AND TEST METHODS FOR 13C-UREA;3. CHANGES IN QC TESTING LOCATIONS; AND 4. CHANGES IN MANUFACTURING LOCATIONS FOR 18KG PROCESS.