Identity
- Trade Name
- 13C-Spirulina GEBT FDA UDI
- Generic Name
- Carbon isotope breath test kit IVD FDA UDI
- Device Name
- 13C-Spirulina Gastric Emptying Breath Test (GEBT) FDA UDI
- Model / Reference
- K021 FDA UDI
- Description
- 13C-Spirulina Gastric Emptying Breath Test (GEBT) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M763K0211 FDA UDI
- PMA Number
- P110015 FDA UDI
- FDA Product Code
- PGE FDA UDI
- GMDN Term
- Carbon isotope breath test kit IVD FDA UDI
Classification
- Device Class
- Class III 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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Carbon isotope breath test kit IVD
13C-Spirulina GEBT by Advanced Breath Diagnostics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon isotope breath test kit IVD.
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
- Advanced Breath Diagnostics
Sources (1)
- FDA UDI 7d886a74-c9e5-4d15-8355-f072c7795ce6 36 fields · synced Jun 1, 2026