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Cardiac Ultra Low Control (CRD CONTROL Ultra Low)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref CQ10428

by Randox Laboratories Limited

Identity

Trade Name
Cardiac Ultra Low Control (CRD CONTROL Ultra Low) EUDAMEDFDA UDI
Generic Name
Multiple cardiac marker IVD, control FDA UDI
Device Name
CARDIAC CONTROL EUDAMED
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Model / Reference
CQ10428 EUDAMEDFDA UDI
Description
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI

Identifiers

Catalog Number
CQ10428 FDA UDI
Primary DI / UDI-DI
05055273217346 EUDAMEDFDA UDI
Basic UDI-DI
50552732BCRDCON001AS EUDAMED
FDA Product Code
JJX FDA UDI
EMDN Code
W0102152004 CARDIAC MARKER CONTROLS EUDAMED
GMDN Term
Multiple cardiac marker 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

Yes

EUDAMED

Animal Tissues

Yes

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

Cardiac Ultra Low Control (CRD CONTROL Ultra Low) 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 9b6d5ade-4a16-480b-9a54-32884df45996 61 fields · synced Jun 18, 2026
  • FDA UDI 6d3a39fb-4038-4011-a4a8-b33225a877cc 36 fields · synced May 30, 2026