Geenius Blood Donor IFU & APF v2.0 binder


Product Overview

Geenius Blood Donor IFU & APF v2.0 binder
Geenius - 12012482


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using a chemiluminescent immunoassay method.


Environmental Conditions

No Data Available


Device Sizes

  • 1 each
    • 1 each


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: QHM

    Device Name: Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

    Device Class: U

    Physical State: May include reagents, buffers, tubes, plates and other components necessary to run the assay

    Definition: For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens

    Submission Type ID: 3

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Enzyme-linked immunosorbant assay, chemiluminescence, other antibody-antigen interaction and detection

    Life Sustain Support Flag: N

    Unclassified Reason: 1

    Implant Flag: N

    Target Area: Human specimens including blood, serum, plasma, urine, other samples

    Regulation Number: 610.40

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 03610522162239

    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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