BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Optilite Prealbumin Control Pack

    Reg #: 9614373 · FEI: 3002808340 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    53
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    The Binding Site Group Ltd.
    Registration Number
    9614373
    FEI Number
    3002808340
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Calthorpe Road, Edgbaston
    City
    BIRMINGHAM
    Country
    GB

    Owner / Operator

    Firm Name
    THE BINDING SITE
    Operator Number
    9008308
    Address
    8 Calthorpe Road,, Edgbaston
    City
    BIRMINGHAM
    State
    GB-NOTA
    Postal Code
    B15 1QT
    Country
    GB
    Correspondent
    Ned Merrick

    US Agent

    Business Name
    The Binding Site, Inc
    Contact Name
    Douglas Anderson
    Address
    6730 Mesa Ridge Road
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 2914550

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Optilite Prealbumin Control Pack Optilite® IgG1 Control Pack Optilite® Freelite® Lambda Free Control Pack Optilite Transferrin Control Pack Alpha 1 Acid Glycoprotein AMR Fluid Optilite Rheumatoid Factor Control Pack Freelite® Kappa AMR Check Fluid SD Optilite® Low Level IgG Control Pack Optilite Alpha-2 Macroglobulin Control Pack Optilite® Hevylite® IgM Kappa Control Pack Optilite® IgG4 Control Pack Cystatin C Analytical Measuring Range Freelite Kappa Free Panel Sample Set B2M Analytical Measuring Range Fluid Freelite® Human Kappa Free Control Pack for use on the Siemens BN™II Optilite® Caeruloplasmin Control Pack IgG S/c Analytical Meas. Range (AMR) Set Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c Systems Optilite® Cystatin C Control Pack Optilite® IgA1 Control Pack Antistreptolysin O AMR Fluid Optilite® IgM Control Pack Freelite® Lambda AMR Check Fluid SD Optilite Low Level Total Protein Controls Freelite® Human Kappa Free Control Pack For use on the Roche Cobas™ c Systems Optilite® IgG Control Pack Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™/IMMAGE™800 Freelite Lambda Free Panel Sample Set Optilite® IgG3 Control Pack Optilite® C1 Inactivator Control Pack Optilite® IgA Control Pack Optilite IgA2 Control Pack Optilite® ?1-Acid Glycoprotein Control Pack Freelite® Panel Sample Set Optilite® Albumin Control Pack Optilite® Hevylite® IgA Kappa Control Pack Optilite® C3c Control Pack Optilite Alpha-1 Antitrypsin Control Pack Optilite® Hevylite IgA Lambda Control Pack Optilite® IgG2 Control Pack Freelite® Human Lambda Free Control Pack for use on the Siemens BN™II Optilite® C4 Control Pack Optilite® Freelite® Kappa Free Control Pack Optilite® Beta-2 Microglobulin Control Pack Optilite® Low Level Albumin Control Pack Optilite Anti-Streptolysin O Control Pack Optilite® IgD Control Pack Optilite® Hevylite® IgM Lambda Control Pack Optilite® Haptoglobin Control Pack IgD Analytical Measuring Range Fluid Human IgD Control Pack for use on the Siemens BN™II Freelite® Human Kappa Free Control Pack For use on the Beckman Coulter IMMAGE™/IMMAGE™800 Optilite® Beta-2 Microglobulin Urine Control Pack

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device