BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
FDA premarket approval P100025/S013 · decided 2018-06-05
Approval details
- PMA number
- P100025
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2018-04-20
- Decision date
- 2018-06-05
- Days to decision
- 46 days
- Decision code
- OK30
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- Changes to testing methods for raw materials and kit reagents.
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