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AMMONIA ETHANOL CONTROL - LEVEL 3 (NH3/EtOH CONTROL 3)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref EA1368

by Randox Laboratories Limited

Identity

Trade Name
AMMONIA ETHANOL CONTROL - LEVEL 3 (NH3/EtOH CONTROL 3) EUDAMEDFDA UDI
Generic Name
Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
Device Name
AMMONIA ETHANOL CONTROL EUDAMED
The Randox Ammonia Ethanol Control - Level 3 is intended for in vitro diagnostic use, in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems. FDA UDI
Model / Reference
EA1368 EUDAMEDFDA UDI
Description
The Randox Ammonia Ethanol Control - Level 3 is intended for in vitro diagnostic use, in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems. FDA UDI

Identifiers

Primary DI / UDI-DI
05055273202113 EUDAMEDFDA UDI
Basic UDI-DI
50552732BAMMCON049C2 EUDAMED
FDA Product Code
JJY FDA UDI
EMDN Code
W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
862.1660 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

AMMONIA ETHANOL CONTROL - LEVEL 3 (NH3/EtOH CONTROL 3) 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 056750a7-01fb-424a-9de8-847e0c865370 61 fields · synced Jul 25, 2026
  • FDA UDI 412a5e00-f56c-4920-8a28-ab6966a6c173 35 fields · synced May 30, 2026