The Binding Site Group Ltd.

FDA Device Registration & Listing · BIRMINGHAM, GB · Registration 9614373

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614373
FEI Number
3002808340
Entity Name
The Binding Site Group Ltd.
City/State/Country
BIRMINGHAM, GB
Establishment Address
8 Calthorpe Road, Edgbaston, BIRMINGHAM B15 1QT, GB
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
THE BINDING SITE (Owner Number: 9008308)
Owner / Operator Contact Address
8 Calthorpe Road,, Edgbaston, BIRMINGHAM, GB-NOTA B15 1QT, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Freelite Mx Kappa Free Kit Optilite Freelite Mx Lambda Free Kit Optilite High Sensitivity C-Reactive Protein Kit Freelite Lambda Olympus kit EXENT® Immunoglobulin Isotypes (GAM) Control Pack Freelite Lambda BNII kit 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2008-12-22
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2019-07-17
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2013-04-03
PDE Immunoglobulin M Kappa Heavy And Light Chain Combined Immunology Class 2 866.5510 2013-04-03
PDF Immunoglobulin M Lambda Heavy And Light Chain Combined Immunology Class 2 866.5510 2013-04-03
CZJ Igd, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-12-05
GOS Antiserum, Fluorescent, C. Diphtheriae Microbiology Class 1 866.3140 2012-03-15
LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control Immunology Class 1 866.5420 2002-01-11
CEF Electrophoretic, Protein Fractionation Clinical Chemistry Class 1 862.1630 1996-08-28
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2002-01-11
DAD Haptoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5460 2002-01-11
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2007-12-03
JRI Cuvette, Thermostated Clinical Chemistry Class 1 862.2050 2022-06-02
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2012-09-19
PDE Immunoglobulin M Kappa Heavy And Light Chain Combined Immunology Class 2 866.5510 2016-03-10
PDF Immunoglobulin M Lambda Heavy And Light Chain Combined Immunology Class 2 866.5510 2016-03-10
DFI Total Spinal-Fluid, Antigen, Antiserum, Control Immunology Class 1 866.5860 2024-09-25
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2015-09-02
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2015-09-02
DAE Complement C9, Antigen, Antiserum, Control Immunology Class 2 866.5240 2015-09-02
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2013-02-19
PCO Immunoglobulin G Lambda Heavy And Light Chain Combined Immunology Class 2 866.5510 2014-02-19
PCN Immunoglobulin G Kappa Heavy And Light Chain Combined Immunology Class 2 866.5510 2014-02-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-02-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2009-02-11
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2009-02-11
DDX Plasminogen, Antigen, Antiserum, Control Immunology Class 1 866.5715 1996-08-28
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2009-05-12
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2015-05-27
JZQ Plates And Equipment, Radial Immunodiffusion Immunology Class 1 866.4800 2002-03-09
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2016-10-19
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2015-07-27
CZJ Igd, Antigen, Antiserum, Control Immunology Class 2 866.5510 2009-12-30
PPM General Purpose Reagent Pathology Class 1 864.4010 2007-08-17
JBQ Antithrombin Iii Quantitation Hematology Class 2 864.7060 2007-11-15
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2021-09-23
DDB Ceruloplasmin, Antigen, Antiserum, Control Immunology Class 2 866.5210 2007-12-03
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2019-07-18
DAK Complement C1q, Antigen, Antiserum, Control Immunology Class 2 866.5240 2007-12-03
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 2004-05-19
OPX Immunoglobulin A Kappa Heavy & Light Chain Combined Immunology Class 2 866.5510 2014-03-20
OPY Igal Heavy & Light Chain Combined Immunology Class 2 866.5510 2014-03-20
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2010-08-18
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2013-06-27
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2019-08-20
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 2013-07-19
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2007-12-06
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2007-12-06
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2007-11-08
DAB Haptoglobin, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5460 2007-11-08
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2010-08-18
DGC Ige, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-11-08
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2013-05-23
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2007-12-05
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2025-06-03
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2025-06-03
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2007-12-05
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2007-12-05
CZJ Igd, Antigen, Antiserum, Control Immunology Class 2 866.5510 2007-11-08
PCO Immunoglobulin G Lambda Heavy And Light Chain Combined Immunology Class 2 866.5510 2016-10-20
PCN Immunoglobulin G Kappa Heavy And Light Chain Combined Immunology Class 2 866.5510 2016-10-20
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2007-12-05
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2019-01-24
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2017-06-05
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2007-12-05
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2018-11-13
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2018-11-13
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2018-11-14
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2007-12-05
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2025-11-19
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2007-12-05
OPY Igal Heavy & Light Chain Combined Immunology Class 2 866.5510 2016-09-01
OPX Immunoglobulin A Kappa Heavy & Light Chain Combined Immunology Class 2 866.5510 2016-09-01
PCN Immunoglobulin G Kappa Heavy And Light Chain Combined Immunology Class 2 866.5510 2018-03-15
PCO Immunoglobulin G Lambda Heavy And Light Chain Combined Immunology Class 2 866.5510 2018-03-15
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2010-01-11
DAE Complement C9, Antigen, Antiserum, Control Immunology Class 2 866.5240 2008-08-13
DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control Immunology Class 2 866.5250 2014-07-22
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2007-10-29
PDF Immunoglobulin M Lambda Heavy And Light Chain Combined Immunology Class 2 866.5510 2016-03-10
PDE Immunoglobulin M Kappa Heavy And Light Chain Combined Immunology Class 2 866.5510 2016-03-10
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2008-02-05
OPX Immunoglobulin A Kappa Heavy & Light Chain Combined Immunology Class 2 866.5510 2015-11-09
OPY Igal Heavy & Light Chain Combined Immunology Class 2 866.5510 2015-11-09
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2015-07-27
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-05-31

Official Correspondent

Ned Merrick

US Agent Details

Damon Loya Business: The Binding Site, Inc Email: damon.loya@thermofisher.com Phone: (858) 4539177

Related Public Records

Same Entity

THE BINDING SITE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012471076 THE BINDING SITE Kings Norton Birmingham, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K022083 The Binding Site, Ltd. HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER 2002-07-16
K041905 Instrumentation Laboratory CO HEMOSIL CALIBRATION PLASMA 2004-09-28
K081103 Siemens Healthcare Diagnostics, Inc. LOCI THYROID CALIBRATOR WITH MODEL RC610 2008-05-23
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2018 The Binding Site Group, Ltd. 2
Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Z-0093-2023 SIEMENS HEALTHCARE DIAGNOSTICS INC 2
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Z-0094-2023 SIEMENS HEALTHCARE DIAGNOSTICS INC 2
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Z-0164-2015 Siemens Healthcare Diagnostics, Inc 2
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0009-2009 Roche Diagnostics Corp. 2
Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of soluable transferrin receptor in serum and plasma.

Similar Registrations

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3012471076 THE BINDING SITE Kings Norton Birmingham, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614373. Last updated year: 2026. Please use registration number 9614373 when referencing this establishment in official correspondence.
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