BREATHTEK UBT FOR H.PYLORI KIT
FDA premarket approval P100025/S008 · decided 2015-03-05
Approval details
- PMA number
- P100025
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BREATHTEK UBT FOR H.PYLORI KIT
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2015-01-13
- Decision date
- 2015-03-05
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- 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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