Fruc Control 1

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: FRUC CONTROL 1 FDA UDI
Generic Name: Fructosamine IVD, control FDA UDI
Device Name: This product is intended for in vitro diagnostic use in the quality control of the Randox Liquid Fructosamine assay on clinical chemistry systems. FDA UDI
Model / Reference: FR2994 FDA UDI
Description: This product is intended for in vitro diagnostic use in the quality control of the Randox Liquid Fructosamine assay on clinical chemistry systems. FDA UDI

Identifiers

Catalog Number: FR2994 FDA UDI
Primary DI / UDI-DI: 05055273203127 FDA UDI
510(k) Number: K023763 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Fructosamine 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Fructosamine IVD, control

Fruc Control 1 by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fructosamine IVD, control.

POINTE SCIENTIFIC Fructosamine Control Set — POINTE SCIENTIFIC, INC. · Class II
Diazyme — Diazyme Laboratories, Inc.
CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 — Carolina Liquid Chemistries Corp. · Class II
Validate — LGC Clinical Diagnostics, Inc. · Class I
Audit MicroControls Linearity DROP LQ Fructosamine for Roche Systems — Aalto Scientific, Ltd.
FRUC CONTROL 3 — Randox Laboratories, Ltd. · Class I

Cleared under the same submission

K023763 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI 4fae1d23-4d5e-4372-b8db-a29ad5dc1de7 37 fields · synced Jun 8, 2026