IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with appropriate IH-Cards.


Product Overview

IH
IH-Titration Solution - 813560100


Device Description

A substance or reactant that is an antibody-free solution intended to be used as a diluent in the immunohaematological testing of a clinical specimen for the semi-quantitative determination of a red blood cell antibody, using a serial dilution or titration technique.


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: KSG

    Device Name: Media, Potentiating For In Vitro Diagnostic Use

    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: 864.9600

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 07611969952205

    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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