PMA
P100025: BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
FDA PMA · Test, urea adult and pediatric (breath), · Meridian Bioscience, Inc.
Key facts
| PMA number | P100025 |
|---|---|
| Trade name | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 |
| Generic name | Test, urea adult and pediatric (breath), |
| Applicant | Meridian Bioscience, Inc. |
| Owner/operator | MERIDIAN BIOSCIENCE, INC. |
| Product code | OZA |
| Approval date | Feb 22, 2012 |
| Docket number | 12M-0207 |
| Notice date | Mar 7, 2012 |
| Establishment registration | 1524213 |
| FEI number | 1524213 |
At a glance
- 10–99 Supplements
- May 26, 2020 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: