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Sodium Electrode

FDA UDI

Class II (US FDA UDI)

by Elitechgroup Inc.

Identity

Trade Name
Sodium Electrode FDA UDI
Generic Name
Sodium (Na+) IVD, kit, ion-selective electrode (ISE) FDA UDI
Device Name
ISE electrode for the measure of Sodium in IVD samples. FDA UDI
Model / Reference
278-001 FDA UDI
Description
ISE electrode for the measure of Sodium in IVD samples. FDA UDI

Identifiers

Catalog Number
278-001 FDA UDI
Primary DI / UDI-DI
03661540304187 FDA UDI
FDA Product Code
JGS FDA UDI
GMDN Term
Sodium (Na+) IVD, kit, ion-selective electrode (ISE) 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

No

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+) IVD, kit, ion-selective electrode (ISE)

Sodium Electrode by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sodium (Na+) IVD, kit, ion-selective electrode (ISE).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elitechgroup Inc.

Sources (1)

  • FDA UDI 8701e094-bdbd-4020-89b9-cb00ba027d33 35 fields · synced May 30, 2026