BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioPlex2200 APLS IgA Reagent Pack

    Reg #: 3032705 · FEI: 3002701146 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    BIO-RAD LABORATORIES, INC.
    Registration Number
    3032705
    FEI Number
    3002701146
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14620 NE North Woodinville Way
    City
    Woodinville
    State
    WA
    ZIP
    98072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103834

    Owner / Operator

    Firm Name
    BIO-RAD LABORATORIES, INC.
    Operator Number
    3022521
    Address
    8415 216th St SE, --
    City
    Woodinville
    State
    WA
    Postal Code
    98072
    Country
    US
    Correspondent
    David - Bhend

    Products

    Device Name Product Code
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV
    System, Test, Anticardiolipin Immunological MID
    Calibrator, Multi-Analyte Mixture JIX
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    BioPlex2200 APLS IgA Reagent Pack BioPlex2200 APLS IgG Control Set BioPlex2200 APLS IgG Calibrator Set BioPlex2200 APLS IgG Reagent Pack BioPlex2200 APLS IgA Calibrator Set BioPlex2200 APLS IgA Control Set

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)