Identity
- Trade Name
- I.S.E. NA FDA UDI
- Generic Name
- Sodium (Na+) electrode IVD FDA UDI
- Device Name
- Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine. FDA UDI
- Model / Reference
- D200-0014 FDA UDI
- Description
- Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine. FDA UDI
Identifiers
- Catalog Number
- D200-0014 FDA UDI
- Primary DI / UDI-DI
- 05055273210521 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
Yes
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
I.s.e. Na by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 825f6c2b-7548-4f00-9a01-eb3430ab2484 36 fields · synced May 29, 2026