Pemphigus Foliaceus Control


Product Overview

Pemphigus Foliaceus Control
IMMCO DIAGNOSTICS - 2216


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to skin in a clinical specimen, using a fluorescent immunoassay method. This test is typically used to aid the diagnosis of skin disorders (e.g., autoimmune bullous dermatoses such as pemphigus vulgaris, paraneoplastic pemphigus, or dermatitis herpetiformis); antibodies detected are typically directed at structural proteins of the skin and/or superficial mucosa (e.g., gliadin, desmoglein, collagen, endomysium).


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00

  • Device Sizes

  • ml
    • ml


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DBL

    Device Name: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: IM

    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: 866.5660

    Third Party Flag: Y

    Medical Specialty: IM


    Device Identifiers

    Device Id: 00845714003707

    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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