Electrode for ABL analyzers

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name: Electrode for ABL analyzers FDA UDI
Generic Name: Creatinine IVD, reagent FDA UDI
Device Name: E8089 Crea B electrode for ABL8XX FDA UDI
Model / Reference: 945-663 FDA UDI
Description: E8089 Crea B electrode for ABL8XX FDA UDI

Identifiers

Catalog Number: 945-663 FDA UDI
Primary DI / UDI-DI: 05700699456632 FDA UDI
FDA Product Code: CGL FDA UDI
CGA FDA UDI
KQI FDA UDI
CGZ FDA UDI
CIG FDA UDI
CEM FDA UDI
KHP FDA UDI
GHS FDA UDI
MQM FDA UDI
JFP FDA UDI
JGS FDA UDI
CHL FDA UDI
GMDN Term: Creatinine IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1225 FDA UDI
862.1345 FDA UDI
864.7455 FDA UDI
862.1170 FDA UDI
862.1110 FDA UDI
862.1600 FDA UDI
862.1450 FDA UDI
864.7425 FDA UDI
862.1113 FDA UDI
862.1145 FDA UDI
862.1665 FDA UDI
862.1120 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Creatinine IVD, reagent

Electrode for ABL analyzers by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Creatinine IVD, reagent.

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Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
ClearChem Diagnostics Inc. Creatinine (Jaffe) — CLEARCHEM DIAGNOSTICS INC. · Class II
CREATININE/ ENDPOINT — STERLING DIAGNOSTICS INC
Alinity — Abbott Laboratories, Inc. · Class II
Alinity — Abbott Laboratories, Inc. · Class II
Piccolo Kidney Check — ABAXIS, INC. · Class II

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: Radiometer Medical ApS

Sources (1)

FDA UDI 7e242a96-9f1c-4bb4-9d40-94d9558e688c 35 fields · synced May 30, 2026