The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test systems to validate performance of the assay.


Product Overview

The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test systems to validate performance of the assay.
POINTE SCIENTIFIC Fructosamine Calibrator - F7546-CAL


Device Description

A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of the glycated serum protein fructosamine in a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LCP

    Device Name: Assay, Glycosylated Hemoglobin

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HE

    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: 864.7470

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 00811727011084

    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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