BEUDAMED
    FDA Registration Active 🇺🇸 United States

    QDXH90 - Histoplasma Yeast CF Antigen

    Reg #: 1627497 · FEI: 1627497 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IMMY, Inc.
    Registration Number
    1627497
    FEI Number
    1627497
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2701 Corporate Centre Dr
    City
    NORMAN
    State
    OK
    ZIP
    73069
    Country
    US

    Regulatory Submissions

    510(k) Number
    K791393

    Owner / Operator

    Firm Name
    IMMUNO-MYCOLOGICS, INC.
    Operator Number
    9916020
    Address
    2701 Corporate Centre Drive, --
    City
    Norman
    State
    OK
    Postal Code
    73069
    Country
    US

    Products

    Device Name Product Code
    Antigens, Histoplasma Capsulatum, All GMJ

    Proprietary Names

    QDXH90 - Histoplasma Yeast CF Antigen H30150-M - Histoplasma Yeast CF Antigen H30150 - Histoplasma Yeast CF Antigen Dilute

    Establishment Types

    Manufacture Medical Device