← Back to catalogue
ISE Disposable Reference Electrode
FDA UDIClass II (US FDA UDI)
by Medica Corp.
Identity
- Trade Name
- ISE Disposable Reference Electrode FDA UDI
- Generic Name
- Reference electrode IVD FDA UDI
- Device Name
- ISE Disposable Reference Electrode for use with EasyElectrolyte Analyzers FDA UDI
- Model / Reference
- 5204 FDA UDI
- Description
- ISE Disposable Reference Electrode for use with EasyElectrolyte Analyzers FDA UDI
Identifiers
- Catalog Number
- 5204 FDA UDI
- Primary DI / UDI-DI
- 00386100001650 FDA UDI
- 510(k) Number
- K000926 FDA UDI
- FDA Product Code
- JGS FDA UDICEM FDA UDICGZ FDA UDI
- GMDN Term
- Reference electrode IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 FDA UDI862.1600 FDA UDI862.1170 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
Yes
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
Yes
FDA UDI
Category: Reference electrode IVD
ISE Disposable Reference Electrode by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reference electrode IVD.
- Membrane for E1001 electrode — Radiometer Medical ApS · Class II
- Reference Electrode — VITALSCIENTIFIC
- Reference Electrode — TOKYO BOEKI MEDISYS INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class I
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class I
- ADVIA® Chemistry Systems Reference Electrode — Siemens Healthcare Diagnostics · Class I
- ABX PENTRA REFERENCE-E — Horiba Abx · Class I
- ISE Reference Electrode — STANBIO LABORATORY, L.P. · Class II
Cleared under the same submission
K000926 also covers:
- Chloride Electrode — Medica Corp.
- EasyElectrolyte Reagent Module, Na/K/Cl Analyzers — Medica Corp.
- ISE Chloride Electrode — Medica Corp.
- ISE Cleaning Solution Kit — Medica Corp.
- ISE Potassium Electrode — Medica Corp.
- ISE Reagent Module — Medica Corp.
- ISE Reagent Pack — Medica Corp.
- ISE Sodium electrode — Medica Corp.
- ISE eChloride Electrode — Medica Corp.
- Na/K/Cl Analyzer — Medica Corp.
- RAPIDChem® 700 Chloride Sensor — Siemens Healthcare Diagnostics
- RAPIDChem® 700 RAPIDPoint® 340/350 Reference Sensor — Siemens Healthcare Diagnostics
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
- Medica Corp.
Sources (1)
- FDA UDI e55e3501-80dd-4ce7-af7f-41d58a37f8a1 37 fields · synced Jun 6, 2026