Lipid and Glucose Measuring System

Product Overview

Lipid and Glucose Measuring System
LipidPlus® Total Cholesterol Test Strips - MD532

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total cholesterol lipid in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 36.00

  • Device Sizes

  • Total Volume: 5 Microliter
    • Total Volume: 5 Microliter

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: CHH

    Device Name: Enzymatic Esterase--Oxidase, Cholesterol

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.1175

    Third Party Flag: N

    Medical Specialty: CH

    Device Identifiers

    Device Id: 10763924532107

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

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