BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    THE BINDING SITE

    Reg #: 3012471076 · FEI: 3012471076 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    172
    Establishment Types
    4
    Classifications
    51

    Registration Details

    Registration Name
    THE BINDING SITE
    Registration Number
    3012471076
    FEI Number
    3012471076
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 27-29, 31-33 Sovereign Road, Kings Norton Business Centre
    City
    Kings Norton Birmingham
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K190686

    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
    Damon Loya
    Address
    9606 Kearny Villa Rd
    City
    San Diego
    State
    CA
    ZIP
    92126
    Country
    US
    Email
    [email protected]
    Phone
    858 4539177

    Products

    Device Name Product Code
    Method, Nephelometric, Immunoglobulins (G, A, M) CFN
    System, Test, C-Reactive Protein DCN
    Ceruloplasmin, Antigen, Antiserum, Control DDB
    Igd, Antigen, Antiserum, Control CZJ
    Calibrator, Multi-Analyte Mixture JIX
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Complement C9, Antigen, Antiserum, Control DAE
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Calibrator, Secondary JIT
    Complement C4, Antigen, Antiserum, Control DBI
    Kappa, Antigen, Antiserum, Control DFH
    Lambda, Antigen, Antiserum, Control DEH
    Total Spinal-Fluid, Antigen, Antiserum, Control DFI
    System, Test, Rheumatoid Factor DHR
    Complement C1q, Antigen, Antiserum, Control DAK
    Antisera, All Types, H. Influenza GRP
    Alpha-2-Macroglobulin, Antigen, Antiserum, Control DEB
    Albumin, Antigen, Antiserum, Control DCF
    Transferrin, Antigen, Antiserum, Control DDG
    Cuvette, Thermostated JRI
    C-Reactive Protein, Antigen, Antiserum, And Control DCK
    Complement C3, Antigen, Antiserum, Control CZW
    Mass Spectrometer For Clinical Multiplex Test Systems OTA
    Mass Spectrometric, Immunoglobulins (G, A, M, D, E) SGG
    General Purpose Reagent PPM
    Plasminogen, Antigen, Antiserum, Control DDX
    Haptoglobin, Antigen, Antiserum, Control DAD
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Alpha-1-Antitrypsin, Antigen, Antiserum, Control DEM
    System, Test, Beta-2-Microglobulin Immunological JZG
    Haptoglobin, Fitc, Antigen, Antiserum, Control DAB
    Ige, Antigen, Antiserum, Control DGC
    Immunoglobulin M Kappa Heavy And Light Chain Combined PDE
    Immunoglobulin M Lambda Heavy And Light Chain Combined PDF
    Immunoglobulin G Lambda Heavy And Light Chain Combined PCO
    Immunoglobulin G Kappa Heavy And Light Chain Combined PCN
    Reagents, Specific, Analyte MVU
    Antiserum, Fluorescent, C. Diphtheriae GOS
    Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control LKL
    Igal Heavy & Light Chain Combined OPY
    Immunoglobulin A Kappa Heavy & Light Chain Combined OPX
    Calibrator, Primary JIS
    Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control DBA
    Complement C5, Antigen, Antiserum, Control DAY
    Test, Cystatin C NDY
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Detergent JCB
    Electrophoretic, Protein Fractionation CEF
    Antithrombin Iii Quantitation JBQ
    Prealbumin, Antigen, Antiserum, Control JZJ
    Plates And Equipment, Radial Immunodiffusion JZQ

    Proprietary Names

    Optilite IgM CSF Kit Optilite C-Reactive Protein Controls Optilite C-Reactive Protein Reagent Optilite C-Reactive Protein Calibrator Optilite Caeruloplasmin Kit Hu IgD BNII latex kit Optilite CH50 Reagent Optilite CH50 Controls Optilite CH50 Calibrator Optilite® IgM Kit Optilite® C4 Kit Optilite Freelite Mx Kappa Free Kit Optilite Freelite Mx Lambda Free Kit Optilite Low Level Total Protein Reagent Optilite Rheumatoid Factor Kit C1q complement NL RID kit ANIT-HAEMOPHILUS B ELI CH50 ELISA assay Optilite® Alpha-2-Macroglobulin Kit Optilite Albumin Kit Optilite® Transferrin Kit Freelite® Human Lambda Free Kit (for use on the Siemens BN™II) (x10) Freelite® Human Lambda Free Kit (for use on the Siemens BN™II) Freelite® Human Kappa Free Kit (for use on the Siemens BN™II) (x10) Freelite® Human Kappa Free Kit (for use on the Siemens BN™II) Bindarid IgD RID kit Optilite IgA CSF Kit TENCELL™ Cuvettes Human CRP EL Nanorid kit Optilite C3c kit Optilite IgA kit EXENT® Elution Buffer 1 EXENT® Mass Calibration Standard 1 EXENT® Analyser EXENT® Wash Solution 1 EXENT® Disposable MALDI Plate Pack Immunoglobulin Isotypes (GAM) for the EXENT Analyser EXENT® Diluent 1 EXENT® HCCA MALDI Matrix Pack Freelite kappa free kit Optilite Sample Diluent 2 Optilite Sample Diluent 1 Optilite Sample Diluent 3 General Purpose Reaction Buffer Optilite Special Wash 1 PLASMINOGEN RID KIT Optilite Haptoglobin kit Optilite High Sensitivity C-Reactive Protein Kit Human Albumin CSF kit for use on SPAplus Freelite Lambda BNII kit Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems Optilite analyser Optilite IgD Kit Human IgD Kit for SPAPLUS Optilite® Alpha-1-Antitrypsin Kit Optilite Beta-2 Microglobulin Kit Hu Haptoglobin NL RID kit Sh anti-human IgE IFE kit Optilite Low Level Albumin Kit Optilite Hevylite IgM Kappa Kit and Optilite Hevylite IgM Lambda Kit Hevylite Human IgG Lambda Kit for use on BNII Hevylite Human IgG Kappa Kit for use on BNII VARIOUS ANALYTE SPECIFIC REAGENTS IgG subclass Olympus kits Human Anti Diphtheria toxoid IgG Optilite IgG4 kit Optilite IgG4 Kit (x10) Freelite Kappa/Lambda Advia kit Freelite Lambda Olympus kit Human Microablumin kit for use on SPAplus kit Optilite Alpha-1 Acid Glycoprotein kit Human albuming NL RID kit Optilite Hevylite IgA Kappa and Lambda Kits Hevylite Human IgA Lambda Kit for use on SPAPLUS Hevylite Human IgA Kappa Kit for use on SPAPLUS Hevylite Human IgG Kappa Kit for use on SPAPLUS Hevylite Human IgG Lambda Kit for use on SPAPLUS EXENT® Immunoglobulin Isotypes (GAM) Control Pack Optilite Freelite Kappa Free Kit (x10) Optilite Freelite Lambda Free Kit Optilite Freelite Lambda Free Kit (x10) Optilite Freelite Kappa Free Kit Complement C2 Calibrator Set Optilite Low Level Total Protein Calibrator Optilite® IgG kit Optilite® IgG2 Kit (x10) Optilite® IgG Kit (x10) Optilite® IgG1 Kit Optilite® IgG1 Kit (x10) Optilite® IgG2 Kit IgG subclass BNII kit, liquid reagent kit Human CH50 calibrator set for use on the SPAPLUS ® Optilite® CH50 Calibrator Optilite C1 Inactivator kit Hu C5 complement RID kit Hevylite Human IgM Lambda Kit for use on Siemens BN II Hevylite Human IgM Kappa Kit for use on Siemens BN II Hevylite Human IgA Kappa Kit for use on Siemens BNII Hevylite Human IgA Lambda Kit for use on Siemens BNII Optilite® Cystatin C Kit Minineph Hu C4 kits Optilite IgA2 kit Optilite IgA1 kit IgA subclass BNII kits Optilite Hevylite IgG Lambda Kit Optilite Hevylite IgG Kappa Kit Hevylite Hu IgM Kappa Kit for SPA PLUS and Hevylite Hu IgM Lambda Kit for SPA PLUS Optilite IgM Kit Hu IgG & IgG1,2,3&4 SC Hitachi kits Optilite® Anti-streptolysin O Kit Optilite IgA Kit Human IgG CSF Kit (for SPAPLUS) Optilite IgG CSF Kit Optilite Beta-2-Microglobulin Urine Kit Washing Solution 4.5% Optilite IgG3 Kit Optilite IgG3 Kit (x10) Optilite® Hevylite® IgA Kappa Control Pack Optilite® Caeruloplasmin Control Pack IgG S/c Analytical Meas. Range (AMR) Set Optilite Alpha-2 Macroglobulin Control Pack Optilite® Hevylite® IgM Kappa Control Pack Optilite® IgA Control Pack Optilite® ?1-Acid Glycoprotein Control Pack Freelite® Human Kappa Free Control Pack For use on the Roche Cobas™ c Systems Cystatin C Analytical Measuring Range B2M Analytical Measuring Range Fluid Optilite® Low Level IgG Control Pack Optilite® Freelite® Lambda Free Control Pack Optilite Prealbumin Control Pack Human IgD Control Pack for use on the Siemens BN™II Freelite Kappa Free Panel Sample Set Freelite® Human Kappa Free Control Pack for use on the Siemens BN™II Optilite® Cystatin C Control Pack Antistreptolysin O AMR Fluid Optilite® Beta-2 Microglobulin Control Pack Freelite® Panel Sample Set Optilite® IgG1 Control Pack Optilite® IgA1 Control Pack Optilite® IgG Control Pack Freelite® Human Lambda Free Control Pack for use on the Siemens BN™II Optilite Transferrin Control Pack Optilite® Hevylite IgA Lambda Control Pack Optilite Low Level Total Protein Controls Optilite® IgG2 Control Pack Optilite IgA2 Control Pack Alpha 1 Acid Glycoprotein AMR Fluid IgD Analytical Measuring Range Fluid Optilite® C1 Inactivator Control Pack Optilite® Beta-2 Microglobulin Urine Control Pack Optilite® Hevylite® IgM Lambda Control Pack Optilite® IgG3 Control Pack Optilite Rheumatoid Factor Control Pack Freelite® Kappa AMR Check Fluid SD Optilite® IgG4 Control Pack Optilite Anti-Streptolysin O Control Pack Freelite® Lambda AMR Check Fluid SD Freelite Lambda Free Panel Sample Set Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c Systems Optilite® Haptoglobin Control Pack Optilite Alpha-1 Antitrypsin Control Pack Optilite® Low Level Albumin Control Pack Optilite® Freelite® Kappa Free Control Pack Optilite® C3c Control Pack Optilite® C4 Control Pack Optilite® IgD Control Pack Optilite® Albumin Control Pack Optilite® IgM Control Pack SERUM PROTEIN ELECTROPHORESIS KIT Hu Anti-thrombin III NL RID kit Optilite Prealbumin Kit RID PLATE READER Human Caeruloplasmin NL RID kit

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device