Product Overview

ANTI-ACTH - AM487-5M


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 the adrenocorticotropic hormone (ACTH) 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: 00810119671509

    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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