Identity
- Trade Name
- ISE Chloride Electrode FDA UDI
- Generic Name
- Chloride (Cl-) electrode IVD FDA UDI
- Model / Reference
- 4834909001 FDA UDI
Identifiers
- Catalog Number
- 4834909001 FDA UDI
- Primary DI / UDI-DI
- 04015630036875 FDA UDI
- 510(k) Number
- K071211 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
Yes
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
No
FDA UDI
Category: Chloride (Cl-) electrode IVD
ISE Chloride Electrode by Roche Diagnostics 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
- Chloride Electrode — Medica Corp. · 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
- ISE Chloride Electrode — Medica Corp. · Class II
- Chloride Electrode — Medica Corp. · Class II
- Chloride Electrode — DIAMOND DIAGNOSTICS Inc
Cleared under the same submission
K071211 also covers:
- Aspartate aminotransferase withwithout pyridoxal phosphate activation — Roche Diagnostics Corp.
- Cardiac CReactive Protein Latex High Sensitive — Roche Diagnostics Corp.
- Glucose HK — Roche Diagnostics Corp.
- ISE Calibrator Kit — Roche Diagnostics Corp.
- ISE Calibrator indirect / urine — Roche Diagnostics Corp.
- ISE Sodium Electrode — Roche Diagnostics 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI b8bc76b3-4842-423e-8847-2fc8dfd5d35c 35 fields · synced May 30, 2026