BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SPIFE A1AT Kit

    Reg #: 1618982 · FEI: 1618982 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HELENA LABORATORIES, CORP.
    Registration Number
    1618982
    FEI Number
    1618982
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1530 Lindbergh Dr
    City
    BEAUMONT
    State
    TX
    ZIP
    77707
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213396

    Owner / Operator

    Firm Name
    HELENA LABORATORIES, CORP.
    Operator Number
    1618982
    Address
    1530 LINDBERGH DRIVE
    City
    Beaumont
    State
    TX
    Postal Code
    77707
    Country
    US
    Correspondent
    Rachel Easley

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Alpha-1-Antitrypsin Kit, Qualitative Phenotype OBZ

    Proprietary Names

    SPIFE A1AT Kit SPIFE A1AT Controls

    Establishment Types

    Manufacture Medical Device