I.s.e. Ref

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: I.S.E. REF FDA UDI
Generic Name: Reference 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: D200-0017 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: D200-0017 FDA UDI
Primary DI / UDI-DI: 05055273210552 FDA UDI
FDA Product Code: JGS FDA UDI
CEM FDA UDI
CGZ FDA UDI
GMDN Term: Reference electrode IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1665 FDA UDI
862.1600 FDA UDI
862.1170 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Reference electrode IVD

I.s.e. Ref 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 2f11f62c-7f30-4fd5-a1f3-caa7ca5a901c 36 fields · synced May 30, 2026