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ETHANOL CALIBRATOR AND CONTROL SET (EtOH CAL/ CONTROL)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref DA2703

by Randox Laboratories Limited

Identity

Trade Name
ETHANOL CALIBRATOR AND CONTROL SET (EtOH CAL/ CONTROL) EUDAMED
EtOH CAL/CONTROL FDA UDI
Generic Name
Ethanol (ETOH) IVD, control FDA UDI
Device Name
ETHANOL CALIBRATOR AND CONTROL SET EUDAMED
The Randox Ethanol Calibrator and Control Set is intended for the calibration and quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum. FDA UDI
Model / Reference
DA2703 EUDAMEDFDA UDI
Description
The Randox Ethanol Calibrator and Control Set is intended for the calibration and quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum. FDA UDI

Identifiers

Catalog Number
DA2703 FDA UDI
Primary DI / UDI-DI
05055273207873 EUDAMEDFDA UDI
Basic UDI-DI
50552732BETHCON051FZ EUDAMED
510(k) Number
K092273 FDA UDI
FDA Product Code
DLJ FDA UDI
LAS FDA UDI
EMDN Code
W0102152009,W0102152209 EUDAMED
GMDN Term
Ethanol (ETOH) IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class II FDA UDI
Regulation Number
862.3200 FDA UDI
862.3280 FDA UDI
Market of Registration
Northern Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

ETHANOL CALIBRATOR AND CONTROL SET (EtOH CAL/ CONTROL) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED ff0c1636-c811-4d4b-a196-71a64d56cd22 61 fields · synced Jul 30, 2026
  • FDA UDI a35943ff-fc12-466c-84df-e7890ae42246 37 fields · synced May 30, 2026