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Cytokine High Sensitivity Controls (ctk Hs Control)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
CYTOKINE HIGH SENSITIVITY CONTROLS (CTK HS CONTROL) FDA UDI
Generic Name
Multiple interleukin/interleukin receptor IVD, control FDA UDI
Device Name
Randox Cytokine high sensitivity controls are intended for use as an assayed quality control in the routine monitoring of accuracy and precision for the analytes listed in this insert. The Randox Cytokine high sensitivity controls are multi-analyte. Each control contains all of the analytes listed overleaf. There are 3 levels of control: low, medium and high; Level 1, 2 and 3 respectively. FDA UDI
Model / Reference
CY5005 FDA UDI
Description
Randox Cytokine high sensitivity controls are intended for use as an assayed quality control in the routine monitoring of accuracy and precision for the analytes listed in this insert. The Randox Cytokine high sensitivity controls are multi-analyte. Each control contains all of the analytes listed overleaf. There are 3 levels of control: low, medium and high; Level 1, 2 and 3 respectively. FDA UDI

Identifiers

Catalog Number
CY5005 FDA UDI
Primary DI / UDI-DI
05055273201956 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple interleukin/interleukin receptor IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Multiple interleukin/interleukin receptor IVD, control

Cytokine High Sensitivity Controls (ctk Hs Control) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple interleukin/interleukin receptor IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI 2aed495e-7c81-49de-b28b-ac168a78fff8 36 fields · synced Jun 8, 2026