BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LOUISVILLE APL DIAGNOSTICS, INC.

    Reg #: 1529254 · FEI: 1000305932 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    LOUISVILLE APL DIAGNOSTICS, INC.
    Registration Number
    1529254
    FEI Number
    1000305932
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    702 9TH ST N STE A
    City
    Texas City
    State
    TX
    ZIP
    77590
    Country
    US

    Regulatory Submissions

    510(k) Number
    K013080

    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,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    System, Test, Anticardiolipin Immunological MID

    Proprietary Names

    LAPL™ aB2GPI HRP ELISA Kit APhL ELISA® IgM HRP Kit APhL ELISA® IgG and IgM HRP Kit APhL ELISA® IgG HRP Kit APL™ ELISA Kit

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device