BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pantex Salivary Direct Testosterone Enzyme Immunoassay (EIA) Kit, Pantex Sample Collection Device

    Reg #: 2018685 · FEI: 2018685 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIO-ANALYSIS, INC.
    Registration Number
    2018685
    FEI Number
    2018685
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1701 BERKELEY ST.
    City
    Santa Monica
    State
    CA
    ZIP
    90404
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133303

    Owner / Operator

    Firm Name
    BIO-ANALYSIS, INC.
    Operator Number
    2018685
    Address
    1701 BERKELEY ST., --
    City
    Santa Monica
    State
    CA
    Postal Code
    90404
    Country
    US

    Products

    Device Name Product Code
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

    Proprietary Names

    Pantex Salivary Direct Testosterone Enzyme Immunoassay (EIA) Kit, Pantex Sample Collection Device

    Establishment Types

    Manufacture Medical Device