The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum.


Product Overview

The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG
Candida albicans IgG ELISA - EIA-3458


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the yeast Candida albicans in a clinical specimen, using an enzyme immunoassay (EIA) method.


Environmental Conditions

No Data Available


Device Sizes

  • Stop Solution
  • Total Volume: 30 Milliliter
  • Wash Solution
  • Enzyme Conjugate
  • Sample Diluent
  • Total Volume: 14 Milliliter
  • Total Volume: 20 Milliliter
  • Substrate Solution
  • Positive Control
  • Negative Control
  • Cut-off Control
  • Total Volume: 2 Milliliter
  • Total Volume: 100 Milliliter
    • Stop Solution
    • Total Volume: 30 Milliliter
    • Wash Solution
    • Enzyme Conjugate
    • Sample Diluent
    • Total Volume: 14 Milliliter
    • Total Volume: 20 Milliliter
    • Substrate Solution
    • Positive Control
    • Negative Control
    • Cut-off Control
    • Total Volume: 2 Milliliter
    • Total Volume: 100 Milliliter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LSG

    Device Name: Candida Species, Antibody Detection

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: MI

    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: 866.3165

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00840239034588

    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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