- Device
- BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
- Applicant
- Meridian Bioscience, Inc.
- PMA number
- P100025
- Supplement
- S013
- Product code
- OZA
- Generic name
- Test, urea adult and pediatric (breath),
- Decision date
- 2018-06-05
- Decision code
- OK30
- Date received
- 2018-04-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to testing methods for raw materials and kit reagents.