PMA supplement
P100025 S013: BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
FDA PMA supplement · 30-Day Notice · Meridian Bioscience, Inc.
Key facts
| Original PMA | P100025 |
|---|---|
| Supplement number | S013 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | 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. |
| Product code | OZA |
| Received date | Apr 20, 2018 |
| Decision date | Jun 5, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: