Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human blood based solutions. It is intended to simulate human patient whole blood samples for the purpose of monitoring the precision of laboratory testing procedures for the following assays: HbA1c. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. Size: 4 x 0.5 mL


Product Overview

Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human blood based solutions. It is intended to simulate human patient whole blood samples for the purpose of monitoring the precision of laboratory testing procedures for the following assays: HbA1c. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. Size: 4 x 0.5 mL
Pointe Scientific, Inc. - H7546-CTL


Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, 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: JPK

    Device Name: Mixture, Hematology Quality Control

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 864.8625

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 00811727014566

    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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