Lyphochek Hemoglobin A2 Control Bilevel MiniPak (A human whole blood assayed Hemoglobin A2 control.)


Product Overview

Lyphochek Hemoglobin A2 Control Bilevel MiniPak (A human whole blood assayed Hemoglobin A2 control.)
Lyphochek - 553X


Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype A2 (HbA2) 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: JCM

    Device Name: Control, Hemoglobin, Abnormal

    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: 864.7415

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 00847661002093

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos