Identity
- Trade Name
- ABX PENTRA SODIUM-E FDA UDI
- Generic Name
- Sodium (Na+) electrode IVD FDA UDI
- Model / Reference
- 3014029448 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005835 FDA UDI
- 510(k) Number
- K052007 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
No
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
Abx Pentra Sodium-E by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sodium (Na+) electrode IVD.
- Sodium electrode — Roche Diagnostics Corp. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Sodium Electrode — Jeol · Class II
- I.S.E. NA — Randox Laboratories, Ltd. · Class II
- Sodium Electrode — Roche Diagnostics Corp. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- ISE Sodium Electrode — Roche Diagnostics Corp. · Class II
- RAPIDChem® 700 RAPIDPoint® 350 Sodium Sensor — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K052007 also covers:
- ABX PENTRA 400 ISE — Horiba Abx
- ABX PENTRA 400 ISE — Horiba Abx
- ABX PENTRA 400 ISE — Horiba Abx
- ABX PENTRA 400 STD — Horiba Abx
- ABX PENTRA 400 STD — Horiba Abx
- ABX PENTRA CHLORIDE-E — Horiba Abx
- ABX PENTRA POTASSIUM-E — Horiba Abx
- ABX PENTRA REFERENCE — Horiba Abx
- ABX PENTRA REFERENCE 280ML — Horiba Abx
- ABX PENTRA REFERENCE-E — Horiba Abx
- ABX PENTRA STANDARD 1 — Horiba Abx
- ABX PENTRA STANDARD 2 — Horiba Abx
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
- Horiba Abx
Sources (1)
- FDA UDI 452d6813-2978-4cc1-9516-df91a79475e8 33 fields · synced May 30, 2026