BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CR2003 - CrAg Lateral Flow Assay

    Reg #: 1627497 · FEI: 1627497 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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
    K112422

    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
    Antisera, Latex Agglutination, Cryptococcus Neoformans GMD

    Proprietary Names

    CR2003 - CrAg Lateral Flow Assay CRSQ25 - CrAg SQ Lateral Flow Assay (CrAg SQ LFA)

    Establishment Types

    Manufacture Medical Device