Identity
- Trade Name
- PyloPlus+ Urea Breath Test Kit FDA UDI
- Generic Name
- Carbon isotope breath test kit IVD FDA UDI
- Model / Reference
- PPUBTK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001810325 FDA UDI
- PMA Number
- P170022 FDA UDI
- FDA Product Code
- OZA FDA UDI
- GMDN Term
- Carbon isotope breath test kit IVD 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carbon isotope breath test kit IVD
PyloPlus+ Urea Breath Test Kit by Arj Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon isotope breath test kit IVD.
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 |
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Manufacturer
- Manufacturer
- Arj Medical, Inc.
Sources (1)
- FDA UDI 84eb304d-31c8-4185-8341-553c6880c0ad 33 fields · synced May 30, 2026