PMA P100025S009

Device: BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S009
Product code: OZA
Decision date: 2015-11-23
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
Approval order 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.

Current openFDA PMA Record#

Device: BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S009
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2015-11-23
Decision code: APPR
Date received: 2015-07-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.