Identity
- Trade Name
- ISE Sodium Electrode FDA UDI
- Generic Name
- Sodium (Na+) electrode IVD FDA UDI
- Model / Reference
- 4838084001 FDA UDI
Identifiers
- Catalog Number
- 4838084001 FDA UDI
- Primary DI / UDI-DI
- 04015630036189 FDA UDI
- 510(k) Number
- K071211 FDA UDI
- FDA Product Code
- JGS FDA UDI
- GMDN Term
- Sodium (Na+) electrode IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 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: Sodium (Na+) electrode IVD
ISE Sodium Electrode by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sodium (Na+) electrode IVD.
- i-STAT — Abbott Point of Care Inc. · Class II
- Sodium Electrode — Jeol · Class II
- I.S.E. NA — Randox Laboratories, Ltd. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- RAPIDChem® 700 RAPIDPoint® 350 Sodium Sensor — Siemens Healthcare Diagnostics · Class II
- Ready Sensor™ GOLD Sodium Sensor — Siemens Healthcare Diagnostics · Class II
- ISE Sodium Electrode — STANBIO LABORATORY, L.P. · Class II
- Na (Sodium) Electrode — TOKYO BOEKI MEDISYS INC. · Class II
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 Chloride 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 107425d6-90dd-4854-a6ea-f466aa93e676 35 fields · synced Jun 1, 2026