VALIDATE® LP Test Set

Primary DI

00859110005746

Basic UDI-DI Code

B-00859110005746

Reference

501ab

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

LGC Clinical Diagnostics, Inc.

VALIDATE LP Calibration Verification / Linearity Test Kit (U.S. Patent #7,244,618 and Canadian Patent #2,579,001) solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: human high density lipoprotein (HDL) and human low density lipoprotein (LDL). Test kits also contain APOA and APOB as structural elements of the HDL and LDL micelles.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).