APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) FDA UDI
Generic Name: Multiple apolipoprotein IVD, control FDA UDI
Device Name: Apolipoprotein A1 & B Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for Apolipoprotein A1 and Apolipoprotein B. FDA UDI
Model / Reference: LV10363 FDA UDI
Description: Apolipoprotein A1 & B Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for Apolipoprotein A1 and Apolipoprotein B. FDA UDI

Identifiers

Catalog Number: LV10363 FDA UDI
Primary DI / UDI-DI: 05055273216448 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Multiple apolipoprotein 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

Yes

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Lot / Batch Number

Yes

FDA UDI

Serial Number

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Multiple apolipoprotein IVD, control

APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Beckman Coulter AU Systems) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple apolipoprotein IVD, control.

K-ASSAY® Apo AI / B Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
APOLIPOPROTEIN A1 & B LINEARITY VERIFIERS (For Roche Systems) (ApoLV-R) — Randox Laboratories, Ltd. · Class I

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 38059dbe-7d93-46c4-9b8c-b60e9ae337ae 36 fields · synced May 30, 2026