BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
FDA premarket approval P100025/S007 · decided 2015-02-03
Approval details
- PMA number
- P100025
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2014-08-08
- Decision date
- 2015-02-03
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- 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 PR
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