BEUDAMED
    FDA Registration Active 🇺🇸 United States

    APhL ELISA® IgG and IgM HRP Kit

    Reg #: 1529254 · FEI: 1000305932 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LOUISVILLE APL DIAGNOSTICS, INC.
    Registration Number
    1529254
    FEI Number
    1000305932
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    702 9TH ST N STE A
    City
    Texas City
    State
    TX
    ZIP
    77590
    Country
    US

    Regulatory Submissions

    510(k) Number
    K933588

    Owner / Operator

    Firm Name
    LOUISVILLE APL DIAGNOSTICS, INC.
    Operator Number
    9008974
    Address
    702 9TH ST N STE A, --
    City
    Texas City
    State
    TX
    Postal Code
    77590
    Country
    US

    Products

    Device Name Product Code
    System, Test, Anticardiolipin Immunological MID

    Proprietary Names

    APhL ELISA® IgG and IgM HRP Kit APhL ELISA® IgG HRP Kit APhL ELISA® IgM HRP Kit

    Establishment Types

    Manufacture Medical Device