BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMMY

    DI: 00816387021152 · Model: CTA2003 · Immuno-Mycologics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    IMMY
    Primary DI
    00816387021152
    Version / Model
    CTA2003
    Company Name
    Immuno-Mycologics, Inc.
    Labeler DUNS
    099550915
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2017-11-13
    Public Version
    3
    Public Version Date
    2022-03-28
    Public Version Status
    Update
    Public Device Record Key
    a9017fdc-c39d-4372-98a5-3ced4562f337

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MIY Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

    GMDN Terms

    Code Name
    62963 Coccidioides immitis immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00816387021152
    Unit of Use 00816387021169