Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012471076

FEI Number

3012471076

Entity Name

THE BINDING SITE

City/State/Country

Kings Norton Birmingham, GB

Establishment Address

Unit 27-29, 31-33 Sovereign Road, Kings Norton Business Centre, Kings Norton Birmingham B30 3HN, GB

Establishment Type(s)

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

Expiration Date (Year)

2026

510(k) Number

K161854

PMA Number

N/A

All Registered 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 BNII) (x10) Freelite® Human Lambda Free Kit (for use on the Siemens BNII) Freelite® Human Kappa Free Kit (for use on the Siemens BNII) (x10) Freelite® Human Kappa Free Kit (for use on the Siemens BNII) 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 Freelite Lambda BNII kit Sh anti-human IgE IFE kit Optilite Low Level Albumin Kit Optilite Freelite Mx Kappa Free Kit Optilite Freelite Mx Lambda Free 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

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	2019-07-18
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2018-03-06
DDB	Ceruloplasmin, Antigen, Antiserum, Control	Immunology	Class 2	866.5210	2013-06-12
CZJ	Igd, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-11-08
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
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
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2010-09-14
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
DFI	Total Spinal-Fluid, Antigen, Antiserum, Control	Immunology	Class 1	866.5860	2024-09-25
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2017-06-05
DAK	Complement C1q, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-03
GRP	Antisera, All Types, H. Influenza	Microbiology	Class 2	866.3300	2003-01-30
DAE	Complement C9, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2008-08-13
DEB	Alpha-2-Macroglobulin, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2014-04-23
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2002-01-11
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2013-02-19
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
CZJ	Igd, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-05
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2019-05-16
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	2022-06-02
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-12-03
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2010-08-18
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2008-12-22
OTA	Mass Spectrometer For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-11-19
SGG	Mass Spectrometric, Immunoglobulins (G, A, M, D, E)	Immunology	Class 2	866.5510	2025-11-19
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2007-12-14
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2007-08-17
DDX	Plasminogen, Antigen, Antiserum, Control	Immunology	Class 1	866.5715	1996-08-28
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2002-01-11
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2018-11-14
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2013-06-27
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2007-12-05
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2007-12-05
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2007-12-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-05-18
CZJ	Igd, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2009-12-30
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2013-07-19
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2009-05-12
DAB	Haptoglobin, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	2007-11-08
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2007-12-05
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-11-08
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2016-10-19
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
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
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
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2003-10-06
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-12-05
GOS	Antiserum, Fluorescent, C. Diphtheriae	Microbiology	Class 1	866.3140	2012-03-15
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2015-07-27
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
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2007-12-05
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2015-05-27
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2002-01-11
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2007-10-29
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
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
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

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
9614373	The Binding Site Group Ltd.	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
K083412	Mitsubishi Kagaku Iatron	PATHFAST HSCRP	2009-03-09
K860138	Sigma Diagnostics, Inc.	NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM	1986-03-28
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

Similar Registrations

Registration Number	Establishment Name	Location
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG
9614373	The Binding Site Group Ltd.	BIRMINGHAM, GB
9680746	Beckman Coulter Ireland Inc	O CALLAGHANS MILLS Clare, IE
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3012963943	Ortho Clinical Diagnostics, K.K.	Shinagawa-ku Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012471076. Last updated year: 2026. Please use registration number 3012471076 when referencing this establishment in official correspondence.