LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R)

FDA UDI

Class I (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name: LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R) FDA UDI
Generic Name: Multiple lipid analyte IVD, control FDA UDI
Device Name: Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Cholesterol, HDL, LDL and Triglycerides. FDA UDI
Model / Reference: LV10344 FDA UDI
Description: Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Cholesterol, HDL, LDL and Triglycerides. FDA UDI

Identifiers

Catalog Number: LV10344 FDA UDI
Primary DI / UDI-DI: 05055273216257 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Multiple lipid 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple lipid analyte IVD, control

LIPID LINEARITY VERIFIERS (For Roche Systems) (LLV-R) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 45a123f2-a12e-4376-b7f8-c706682652e6 36 fields · synced May 30, 2026