Identity
- Trade Name
- Potassium Electrode FDA UDI
- Generic Name
- Potassium (K+) electrode IVD FDA UDI
- Model / Reference
- CD-476270D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403013319 FDA UDI
- GMDN Term
- Potassium (K+) electrode IVD FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Potassium (K+) electrode IVD
Potassium Electrode by DIAMOND DIAGNOSTICS Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Potassium (K+) electrode IVD.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Potassium Electrode — Medica Corp. · Class II
- Ready Sensor™ GOLD Potassium Sensor — Siemens Healthcare Diagnostics · Class II
- Alfa Wassermann — Alfa Wassermann, Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor — Siemens Healthcare Diagnostics · Class II
- ISE Potassium Electrode — STANBIO LABORATORY, L.P. · Class II
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DIAMOND DIAGNOSTICS Inc
Sources (1)
- FDA UDI dfe73b2f-81e0-4d64-9647-20aaf878d277 32 fields · synced May 30, 2026