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Fe

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
Fe FDA UDI
Generic Name
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry FDA UDI
Device Name
The product is an in vitro diagnostic test intended for the quantitative determination of Iron in serum FDA UDI
Model / Reference
SI2818 FDA UDI
Description
The product is an in vitro diagnostic test intended for the quantitative determination of Iron in serum FDA UDI

Identifiers

Catalog Number
SI2818 FDA UDI
Primary DI / UDI-DI
05055273206203 FDA UDI
510(k) Number
K974604 FDA UDI
FDA Product Code
JMO FDA UDI
GMDN Term
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1415 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: Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

Fe by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry.

Cleared under the same submission

K974604 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 f7c2d365-945f-4068-91c0-895259e247ef 37 fields · synced May 29, 2026