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IgE CAL SET

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
IgE CAL SET FDA UDI
Generic Name
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator FDA UDI
Device Name
This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems. FDA UDI
Model / Reference
IE2492 FDA UDI
Description
This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems. FDA UDI

Identifiers

Catalog Number
IE2492 FDA UDI
Primary DI / UDI-DI
05055273203912 FDA UDI
510(k) Number
K010855 FDA UDI
FDA Product Code
DGC FDA UDI
GMDN Term
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator

IgE CAL SET by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator.

Cleared under the same submission

K010855 also covers:

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 647d1d8a-f790-4e63-9c40-04fd17effcd4 37 fields · synced Jun 8, 2026