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BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) FDA UDI
- Generic Name
- Helicobacter pylori urease IVD, kit, chromogenic FDA UDI
- Device Name
- This is the Metabolic Solutions Kit version of the kit. FDA UDI
- Model / Reference
- 01M FDA UDI
- Description
- This is the Metabolic Solutions Kit version of the kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857335005039 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Helicobacter pylori urease IVD, kit, chromogenic
BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) by Otsuka America Pharmaceutical Inc — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Helicobacter pylori urease IVD, kit, chromogenic.
- Serim® PyloriTek® Test Kit — SERIM RESEARCH CORP. · Class I
- BreathTek UBT for H. pylori — MERIDIAN BIOSCIENCE, INC. · Class III
- Serim® PyloriTek® Test Kit — SERIM RESEARCH CORP. · Class I
- PyloPlus+ Rapid Urease Test — Arj Medical, Inc. · Class I
- Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA — MERIDIAN BIOSCIENCE, INC. · Class III
- 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
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 |
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Manufacturer
- Manufacturer
- Otsuka America Pharmaceutical Inc
Sources (1)
- FDA UDI 144744b1-e8ca-476b-b141-2dbe4836e412 33 fields · synced May 30, 2026