Lipid and Glucose Measuring System


Product Overview

Lipid and Glucose Measuring System
LipidPlus® Glucose Test Strips - MD540


Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 36.00

  • Device Sizes

  • Total Volume: 0.3 Microliter
    • Total Volume: 0.3 Microliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JJX

    Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

    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: 862.1660

    Third Party Flag: N

    Medical Specialty: CH


    Code: CGA

    Device Name: Glucose Oxidase, Glucose

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 862.1345

    Third Party Flag: Y

    Medical Specialty: CH


    Code: NBW

    Device Name: System, Test, Blood Glucose, Over The Counter

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: 862.1345

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00763924540105

    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


    Device Id: 10763924540102

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00763924540105

    Package Quantity: 2

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


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