Identity
- Trade Name
- BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0 FDA PMA
- Generic Name
- Test, urea adult and pediatric (breath), FDA PMA
Identifiers
- PMA Number
- P100025 FDA PMA
- FDA Product Code
- OZA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3110 FDA PMA
- Regulation Number
- 866.3110 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
Breath Tek Ubtfor H. Pylori Kit by Meridian Bioscience, Inc. (test, urea adult and pediatric (breath),) — Class III — FDA_PMA — listed in FDA PMA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100025 | Class III | Active |
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Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA PMA P100025 24 fields · synced Jun 18, 2026