Assayed Urine Control - Level 2 (urn Asy Control 2)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: ASSAYED URINE CONTROL - LEVEL 2 (URN ASY CONTROL 2) FDA UDI
Generic Name: Multiple urine analyte IVD, control FDA UDI
Model / Reference: AU2352 FDA UDI

Identifiers

Catalog Number: AU2352 FDA UDI
Primary DI / UDI-DI: 05055273200539 FDA UDI
510(k) Number: K043266 FDA UDI
FDA Product Code: JJW FDA UDI
GMDN Term: Multiple urine analyte 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: Multiple urine analyte IVD, control

Assayed Urine Control - Level 2 (urn Asy Control 2) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Multiple urine analyte IVD, control.

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iChem® VELOCITY™ — BECKMAN COULTER IRELAND INC. · Class I
ABX PENTRA URINE CONTROL L/H — Horiba Abx · Class I
K-ASSAY® Microalbumin Urine Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL — QUANTIMETRIX CORP. · Class I
qUAntify — Bio-Rad Laboratories · Class I

Cleared under the same submission

K043266 also covers:

ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3) — 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

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Manufacturer

Manufacturer: Randox Laboratories, Ltd.

Sources (1)

FDA UDI 0a372464-52be-4ca3-a87f-835edccfd70b 34 fields · synced Jun 1, 2026