BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    The Binding Site Group Ltd.

    Reg #: 9614373 · FEI: 3002808340 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    171
    Establishment Types
    3
    Classifications
    50

    Registration Details

    Registration Name
    The Binding Site Group Ltd.
    Registration Number
    9614373
    FEI Number
    3002808340
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8 Calthorpe Road, Edgbaston
    City
    BIRMINGHAM
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K081827

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

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device