Positive Control for Solidscreen II on TANGO instruments; 4 ml


Product Overview

Positive Control for Solidscreen II on TANGO instruments; 4 ml
Solidscreen II-Control - 806514100


Device Description

A material containing antibodies to Rh(D) red blood cell antigens [RH001] from the Rhesus system intended to be used in immunohaematological testing of a clinical specimen, to verify the performance of an antibody screening assay that is used for detecting red cell alloantibodies.


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: KSZ

    Device Name: System, Test, Automated Blood Grouping And Antibody

    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: 864.9175

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 07611969951390

    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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