Fructosamine (fruc)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: FRUCTOSAMINE (FRUC) FDA UDI
Generic Name: Fructosamine IVD, kit, spectrophotometry FDA UDI
Model / Reference: FR4030 FDA UDI

Identifiers

Catalog Number: FR4030 FDA UDI
Primary DI / UDI-DI: 05055273208733 FDA UDI
510(k) Number: K110188 FDA UDI
FDA Product Code: JJX FDA UDI
JIT FDA UDI
LCP FDA UDI
GMDN Term: Fructosamine IVD, kit, spectrophotometry FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1150 FDA UDI
864.7470 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

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, kit, spectrophotometry

Fructosamine (fruc) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fructosamine IVD, kit, spectrophotometry.

Fructosamine — Roche Diagnostics Corp. · Class II
Fructosamine — POINTE SCIENTIFIC, INC. · Class II
Fructosamine — Roche Diagnostics Corp. · Class II
Atellica CH Fruc — Siemens Healthcare Diagnostics · Class II
CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 — Carolina Liquid Chemistries Corp. · Class II
Fructosamine — Roche Diagnostics Corp. · Class II
POINTE SCIENTIFIC Fructosamine — POINTE SCIENTIFIC, INC. · Class II

Cleared under the same submission

K110188 also covers:

FRUC — Randox Laboratories, Ltd.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI ec28f91a-962c-4c3e-8f4f-4f9276996b98 34 fields · synced Jun 1, 2026