The PREMIER Coccidioides enzyme immunoassay (EIA) is for the qualitative detection of IgM and IgG antibodies directed against the TP and CF antigens of Coccidioides immitis in serum and cerebrospinal fluid (CSF).


Product Overview

The PREMIER Coccidioides enzyme immunoassay (EIA) is for the qualitative detection of IgM and IgG antibodies directed against the TP and CF antigens of Coccidioides immitis in serum and cerebrospinal fluid (CSF).
PREMIER Coccidioides - 603096


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the fungus Coccidioides immitis in a clinical specimen, using a precipitation/immunodiffusion method.


Environmental Conditions

  • Handling 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: MIY

    Device Name: Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

    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: 866.3135

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00840733101236

    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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