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Soluble Transferrin Receptors Controls (stfr Control)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref TF10162

by Randox Laboratories Limited

Identity

Trade Name
SOLUBLE TRANSFERRIN RECEPTORS CONTROLS (STFR CONTROL) EUDAMEDFDA UDI
Generic Name
Soluble transferrin receptor IVD, control FDA UDI
Device Name
SOLUBLE TRANSFERRIN RECEPTORS CONTROL EUDAMED
The Randox Soluble Transferrin Receptors controls are intended for use, in the control of Soluble Transferrin Receptors assays. FDA UDI
Model / Reference
TF10162 EUDAMEDFDA UDI
Description
The Randox Soluble Transferrin Receptors controls are intended for use, in the control of Soluble Transferrin Receptors assays. FDA UDI

Identifiers

Catalog Number
TF10162 FDA UDI
Primary DI / UDI-DI
05055273215601 EUDAMEDFDA UDI
Basic UDI-DI
50552732BSTFCON103QT EUDAMED
FDA Product Code
JJX FDA UDI
EMDN Code
W0102152006 ANAEMIA RELATED/VITAMIN CONTROLS EUDAMED
GMDN Term
Soluble transferrin receptor 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

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

Soluble Transferrin Receptors Controls (stfr 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 7d7aab68-0a24-4e93-ab4a-aa3f819dba3d 61 fields · synced Jun 20, 2026
  • FDA UDI 6287fc01-3eee-43c2-b877-e94a9c48ff3d 36 fields · synced May 30, 2026