Identity
- Trade Name
- Potassium Electrode FDA UDI
- Generic Name
- Potassium (K+) IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- ISE electrode for the measurement of Potassium in IVD samples. FDA UDI
- Model / Reference
- 279-001 FDA UDI
- Description
- ISE electrode for the measurement of Potassium in IVD samples. FDA UDI
Identifiers
- Catalog Number
- 279-001 FDA UDI
- Primary DI / UDI-DI
- 03661540304156 FDA UDI
- FDA Product Code
- CEM FDA UDI
- GMDN Term
- Potassium (K+) IVD, kit, ion-selective electrode (ISE) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Potassium (K+) IVD, kit, ion-selective electrode (ISE)
Potassium Electrode by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Potassium (K+) IVD, kit, ion-selective electrode (ISE).
- Potassium Electrode — Roche Diagnostics Corp. · Class II
- Potassium Electrode — Roche Diagnostics Corp. · Class II
- Electrode for ABL analyzers — Radiometer Medical ApS · Class II
- Roche 9180 Potassium electrode — Roche Diagnostics Corp. · Class II
- Potassium Electrode — VITALSCIENTIFIC
- ADVIA® Chemistry Electrode K — Siemens Healthcare Diagnostics · Class II
- Membrane for E722 electrode — Radiometer Medical ApS · Class II
- Potassium electrode — Roche Diagnostics Corp. · 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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elitechgroup Inc.
Sources (1)
- FDA UDI db07ab70-8be1-429c-a346-ef1d8777490f 35 fields · synced May 30, 2026