BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
FDA premarket approval P100025/S009 · decided 2015-11-23
Approval details
- PMA number
- P100025
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2015-07-16
- Decision date
- 2015-11-23
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR (1) A NEW REGULATORY ANALYTICAL REFERENCE METHOD FOR ANALYSIS OF THE FINAL DRUG PRODUCT, PRANACTIN-CITRIC, THE DRUG COMPONENT OF THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT); AND (2) THE ADDITION OF AAIPHARMA SERVICES CORPORATION (AAIPHARMA) IN WILMINGTON, NORTH CAROLINA (FEI NUMBER 1049418) AS A SECOND ANALYTICAL TESTING FACILITY FOR PRANACTIN-CITRIC.
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