Product Overview

ANTI-CDX-2 - AM392-5M


Device Description

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of homeobox protein CDX-2, also referred to as caudal-type homeobox protein 2, in a clinical specimen.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store at 2-8°C

  • Device Sizes

  • Total Volume: 6 Milliliter
    • Total Volume: 6 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NJT

    Device Name: Immunohistochemistry Reagents And Kits

    Device Class: 1

    Physical State: N/A

    Definition: according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.

    Submission Type ID: 4

    Review Panel: PA

    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: 864.1860

    Third Party Flag: N

    Medical Specialty: HE


    Device Identifiers

    Device Id: 00810119670205

    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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