Identity
- Trade Name
- Reference Electrode FDA UDI
- Generic Name
- Reference electrode IVD FDA UDI
- Device Name
- ISE Reference Electrode for use with EasyLyte analyzers FDA UDI
- Model / Reference
- 2103 FDA UDI
- Description
- ISE Reference Electrode for use with EasyLyte analyzers FDA UDI
Identifiers
- Catalog Number
- 2103 FDA UDI
- Primary DI / UDI-DI
- 00386100002985 FDA UDI
- 510(k) Number
- K864872 FDA UDI
- FDA Product Code
- CEM FDA UDIJGS FDA UDI
- GMDN Term
- Reference electrode IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 FDA UDI862.1665 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
Reference Electrode by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K864872 also covers:
- Bi-Level Quality Control Kit — Medica Corp.
- Capillary Adapter Cleaning Kit — Medica Corp.
- Capillary tubes — Medica Corp.
- Internal Filling Solution — Medica Corp.
- Membrane Assembly — Medica Corp.
- Na/K Analyzer — Medica Corp.
- Na/K Solution Pack — Medica Corp.
- Na/K Solution Pack — Medica Corp.
- Potassium Electrode — Medica Corp.
- Sodium Electrode — Medica Corp.
- Tri-Level Quality Control Kit — Medica Corp.
- Wash Solution — Medica Corp.
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 |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA UDI 4db59249-11e0-48db-92b3-4e2f3aa5c665 37 fields · synced May 30, 2026