← Back to catalogue
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA FDA UDI
- Generic Name
- Helicobacter pylori urease IVD, kit, chromogenic FDA UDI
- Device Name
- The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori. FDA UDI
- Model / Reference
- 2.0 FDA UDI
- Description
- The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori. FDA UDI
Identifiers
- Catalog Number
- BRTKCALC FDA UDI
- Primary DI / UDI-DI
- 00840733101458 FDA UDI
- PMA Number
- P100025 FDA UDI
- FDA Product Code
- OZA FDA UDI
- GMDN Term
- Helicobacter pylori urease IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 866.3110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Helicobacter pylori urease IVD, kit, chromogenic
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA by Meridian Bioscience, Inc. — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Helicobacter pylori urease IVD, kit, chromogenic.
- BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) — Otsuka America Pharmaceutical Inc · Class III
- Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA — Otsuka America Pharmaceutical Inc · Class III
- Serim® PyloriTek® Test Kit — SERIM RESEARCH CORP. · Class I
- BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) — Otsuka America Pharmaceutical Inc · Class III
- Serim® PyloriTek® Test Kit — SERIM RESEARCH CORP. · Class I
- PyloPlus+ Rapid Urease Test — Arj Medical, Inc. · Class I
- BreathTek UBT for H. pylori — MERIDIAN BIOSCIENCE, INC. · Class III
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 3475f7ef-0fa5-4337-8583-51e04102b3b3 36 fields · synced Jun 8, 2026