BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SEFRIA™ Methamphetamine Oral Fluid Enzyme Immunoassay 100 mL Kit

    Reg #: 2032598 · FEI: 3003789989 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AMEDITECH, INC.
    Registration Number
    2032598
    FEI Number
    3003789989
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9940 Mesa Rim Rd
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Owner / Operator

    Firm Name
    Abbott
    Operator Number
    9006731
    Address
    100 Abbott Park Road, Dept. RX51/J55/MS 6134
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Test, Methamphetamine, Employment And Insurance Testing, Exempt PVD

    Proprietary Names

    SEFRIA™ Methamphetamine Oral Fluid Enzyme Immunoassay 100 mL Kit SEFRIA™ Methamphetamine Oral Fluid Enzyme Immunoassay 500 mL Kit SEFRIA™ Ecstasy Oral Fluid Enzyme Immunoassay 500 mL kit SEFRIA™ Ecstasy Oral Fluid Enzyme Immunoassay 100 mL kit eCup+ Drug Screening Device (REF 94615)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device