Identity
- Trade Name
- Chloride Electrode FDA UDI
- Generic Name
- Chloride (Cl-) electrode IVD FDA UDI
- Device Name
- ISE Chloride Electrode for use with EastLyte analyzers FDA UDI
- Model / Reference
- 2113 FDA UDI
- Description
- ISE Chloride Electrode for use with EastLyte analyzers FDA UDI
Identifiers
- Catalog Number
- 2113 FDA UDI
- Primary DI / UDI-DI
- 00386100003050 FDA UDI
- 510(k) Number
- K895936 FDA UDI
- FDA Product Code
- CGZ FDA UDI
- GMDN Term
- Chloride (Cl-) electrode IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1170 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: Chloride (Cl-) electrode IVD
Chloride Electrode by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chloride (Cl-) electrode IVD.
- ABX PENTRA CHLORIDE-E — Horiba Abx · Class II
- CL ELECTRODE, ISE MODULE — Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- I.S.E. CL — Randox Laboratories, Ltd. · Class II
- Chloride Electrode — DIAMOND DIAGNOSTICS Inc
- cobas b 221 Chloride Electrode — Roche Diagnostics Corp. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Alfa Wassermann — Alfa Wassermann, Inc. · Class II
Cleared under the same submission
K895936 also covers:
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 b54df7d4-0888-4e83-bd94-e1a41003c1fd 37 fields · synced May 30, 2026