ISE Reference Electrode

FDA UDI

Class II (US FDA UDI)

by Stanbio Laboratory, L.p.

Identity

Trade Name: ISE Reference Electrode FDA UDI
Generic Name: Reference electrode IVD FDA UDI
Device Name: Ion-Selective Reference Electrode for the determination of sodium, potassium, and chloride in serum. FDA UDI
Model / Reference: 20270473 FDA UDI
Description: Ion-Selective Reference Electrode for the determination of sodium, potassium, and chloride in serum. FDA UDI

Identifiers

Catalog Number: 20270473 FDA UDI
Primary DI / UDI-DI: 00657498001875 FDA UDI
FDA Product Code: JIX FDA UDI
GMDN Term: Reference electrode IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Reference electrode IVD

ISE Reference Electrode by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reference electrode IVD.

Membrane for E1001 electrode — Radiometer Medical ApS · Class II
Reference Electrode — VITALSCIENTIFIC
Membrane Assembly — Medica Corp. · Class II
Reference Electrode — TOKYO BOEKI MEDISYS INC.
PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class I
PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class I
ADVIA® Chemistry Systems Reference Electrode — Siemens Healthcare Diagnostics · Class I
ABX PENTRA REFERENCE-E — Horiba Abx · Class I

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: Stanbio Laboratory, L.p.

Sources (1)

FDA UDI 53ed3822-9d6a-4842-9694-6b61794672fa 36 fields · synced May 30, 2026