Assure® Dose High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with CS insert.)


Product Overview

Assure® Dose High (Level 2) Control Solution contains a known amount of glucose that reacts with the test strips. Compare the control solution test result with range printed on the test strip bottle label. (Mailer packaged with CS insert.)
Assure® Dose High (Level 2) Control Solution - 502005


Device Description

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 35.00

  • Device Sizes

    No Data Available


    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


    Device Identifiers

    Device Id: 00015482502058

    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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