BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kallestad mounting Medium

    Reg #: 3032705 · FEI: 3002701146 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    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
    K810863

    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
    Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control DBM

    Proprietary Names

    Kallestad mounting Medium Kallestad HEp-2 Slide, 24-Well, 8/PK Kallestad Hep-2, 6-well Kit, 48 tests Kallestad HEp-2 Patient Sample Diluent, 100 mL Kallestad FITC Conjugate, 100 mL Kallestad FITC Conjugate Kallestad HEp-2 Kallestad Positive nDNA Pattern Control Kallestad Counterstain Kallestad Universal Conjugate, 100 ml Evans Blue Counterstain Kallestad HEp-2 12-well Kit, 60 tests Kallestad HEp-2 12-well Kit, 240 tests Kallestad HEp-2 Slide, 12-Well, 20/PK Kallestad HEp-2 Slide, 12-Well, 100/PK

    Establishment Types

    Manufacture Medical Device