ORTHO® Rh-hr Control (Human and Bovine)


Product Overview

ORTHO® Rh
ORTHO - 715480


Device Description

A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.


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: DGR

    Device Name: Whole Human Serum, Antigen, Antiserum, Control

    Device Class: 1

    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: 866.5700

    Third Party Flag: N

    Medical Specialty: IM


    Device Identifiers

    Device Id: 10758750003419

    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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