The Binding Site, Ltd.
Medical device manufacturer in Birmingham, GB.
125510(k) clearances
0PMA approvals
0recalls
Device types
- CFN Method, Nephelometric, Immunoglobulins (G… 15
- DFH Kappa, Antigen, Antiserum, Control 8
- DEH Lambda, Antigen, Antiserum, Control 7
- JZG System, Test, Beta-2-Microglobulin… 6
- MID System, Test, Anticardiolipin Immunological 5
- LLL Extractable Antinuclear Antibody, Antigen… 5
- CZJ Igd, Antigen, Antiserum, Control 4
- MSV System,Test,Antibodies,B2 - Glycoprotein I… 4
- MOB Test System, Antineutrophil Cytoplasmic… 4
- CFQ Radioimmunoassay, Immunoglobulins (G, A, M) 4
- DCK C-Reactive Protein, Antigen, Antiserum, And… 3
- MVM Autoantibodies, Endomysial(Tissue… 3
- MST Antibodies, Gliadin 3
- DAK Complement C1q, Antigen, Antiserum, Control 2
- DEM Alpha-1-Antitrypsin, Antigen, Antiserum… 2
- JZO System, Test, Thyroid Autoantibody 2
- DDG Transferrin, Antigen, Antiserum, Control 2
- DBI Complement C4, Antigen, Antiserum, Control 2
- DFZ Igg (Gamma Chain Specific), Antigen… 2
- JJN Apparatus, Electrophoresis, For Clinical Use 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH · Traditional | 01/24/2024SE |
| K140105 | Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for…OPX · Traditional | 03/18/2014SE |
| K132555 | Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitPCN · Traditional | 12/20/2013SE |
| K103824 | Human Iga Liquid Reagent Kit for Use on SPA PlusCFN · Traditional | 02/27/2012SE |
| K100455 | Spaplus AnalyzerDBI · Traditional | 09/03/2010SE |
| K090920 | Human Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P)CFN · Traditional | 12/30/2009SE |
| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | 12/28/2009SE |
| K083289 | Human BETA-2 Microglobulin KitJZG · Traditional | 05/06/2009SE |
| K082129 | Human Igm Liquid Reagent Kit for Use on the Spaplus AnalyzerCFN · Traditional | 02/10/2009SE |
| K081827 | Human Iga Liquid Reagent Kit for Use on SpaplusCFN · Traditional | 12/19/2008SE |
| K081674 | Bindazyme Human Anti-Gliadin (MGP), Igg Eia Kit; Bindazyme Human Anti-Gliadin (MGP) Iga…MST · Traditional | 10/15/2008SE |
| K080384 | Human Cystatin C Kit for Use on Modular P AnalyserNDY · Traditional | 06/06/2008SE |
| K072889 | Human Igg Subclass Liquid Reagent Kits for Use on the Spaplus AnalyserCFN · Traditional | 02/01/2008SE |
| K072166 | Cystatin C Kit for Use on the Spaplus AnalyzerNDY · Traditional | 01/24/2008SE |
| K070900 | Freelite Human Kappa and Lambda Free Diagnostic Test Kits for Use on the Roche Cobas…DFH · Traditional | 11/30/2007SE |
| K062372 | Freelite Human Kappa and Lambda Free Kits for Use on the Spaplus AnalyzerDFH · Traditional | 06/21/2007SE |
| K062183 | Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay KitLRM · Traditional | 11/21/2006SE |
| K051299 | Igd Diagnostic Test KitsCZJ · Traditional | 11/23/2005SE |
| K051915 | Freelite Human Kappa and Lambda Free Kits for Use on the Bayer Advia 1650 AnalyzerDFH · Traditional | 09/06/2005SE |
| K042579 | Bindazyme Human Asca Igg and Iga Eia Diagnostic Test KitNBT · Traditional | 07/28/2005SE |
| K042152 | Binding Site Igg Sublcass Olympus KitsCFN · Traditional | 11/22/2004SE |
| K041891 | Minineph Human Rheumatoid Factor KitDHR · Traditional | 11/05/2004SE |
| K040466 | Bindazyme Human Anti Tissue Transglutaminase Iga and Igg Eia Diagnostic Test KitsMVM · Traditional | 07/16/2004SE |
| K040009 | Freelite Human Kappa and Lambda KitsDFH · Traditional | 03/11/2004SE |
| K033811 | Freelite Human Kappa and Lambda Free Kits for Use on the Olympus Au AnalyzerDEH · Traditional | 01/30/2004SE |
| K032240 | Bindazyme Human Anti-Phosphatidylserine Iga, Igg and Igm Enzyme Immunoassay KitMID · Traditional | 09/29/2003SE |
| K031563 | Bindazyme CLQ Cic Eia KitDAK · Traditional | 09/10/2003SE |
| K031016 | Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer IIDEH · Traditional | 07/15/2003SE |
| K030238 | Bindazyme Anti-Mitochondria M2 Iggam Eia KitDBM · Traditional | 03/24/2003SE |
| K023131 | Freelite Human Lambda Free KitDEH · Traditional | 01/21/2003SE |
| K023009 | Freelite Human Kappa and Human Lambda Free Kits for Use on the Hitachi 911/912 AnalyzerDFH · Traditional | 01/21/2003SE |
| K014270 | Minineph Human B2-MICROGLOBULIN KitJZG · Traditional | 08/15/2002SE |
| K022083 | Human Igg Subclass Kit for Use on the Beckman Immage AnalyserCFN · Traditional | 07/16/2002SE |
| K021081 | Human Igg Subclass Liquid Reagent Kits for Use on the Hitachi 911/7070 Turbidimetric…DFZ · Traditional | 06/17/2002SE |
| K012296 | Human Igg Subclass Liquid Reagent Kits, Product Code LK001.TCFN · Traditional | 08/31/2001SE |
| K012292 | Human Igg Subclass Liquid Reagent Kits, Product Code LK001.TBCFN · Traditional | 08/31/2001SE |
| K012295 | Human Igg Subclass Liquid Reagent Kits, Product Code NK001.TCFN · Traditional | 08/20/2001SE |
| K012291 | Human Igg Subclass Liquid Reagent Kits, Product Code LK001.TACFN · Traditional | 08/20/2001SE |
| K011663 | Minineph A-1 Antitrypsin Antiserum, High and Low Serum ControlsDEM · Traditional | 07/30/2001SE |
| K011662 | Minineph A-1 Transferrin Antiserum, High and Low Serum ControlDDG · Traditional | 07/30/2001SE |
| K010441 | Freelite Kappa Free KitDEH · Traditional | 04/26/2001SE |
| K010440 | Freelite Lambda Free KitDEH · Traditional | 04/26/2001SE |
| K010147 | Ena Eia KitLLL · Traditional | 03/01/2001SE |
| K010146 | Ena Eia Kit RangeLLL · Traditional | 03/01/2001SE |
| K010148 | Ena Screen Eia KitLLL · Traditional | 02/23/2001SE |
| K004019 | Ana Eia Diagnostic Test KitLJM · Traditional | 02/15/2001SE |
| K003671 | Lambda Immage Freelite KitDEH · Traditional | 02/01/2001SE |
| K003669 | Kappa Immage Freelite KitDFH · Traditional | 02/01/2001SE |
| K002564 | Sheep Anti-Human Kappa Free Light Chain Immunofixation Grade KitDFH · Traditional | 10/26/2000SE |
| K002563 | Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade KitDEH · Traditional | 10/26/2000SE |
| K002561 | Sheep Anti-Human Igd Immunofixation Grade KitCZJ · Traditional | 10/26/2000SE |
| K002560 | Sheep Anti-Human Ige Immunofixation Grade KitDGC · Traditional | 10/26/2000SE |
| K001127 | Anca Combi Diagnostic Kit with If-Aim TechnologyMOB · Traditional | 08/30/2000SE |
| K001636 | C-Reactive Protein Antiserum KitDCK · Traditional | 08/24/2000SE |
| K001556 | HEP-2 Ana Test System with If-Aim TechnologyDHN · Traditional | 08/21/2000SE |
| K991804 | Bindazyme ANTI-B2 Screen Eia Test Kit.MSV · Traditional | 05/05/2000SE |
| K991803 | Bindazyme Anti B2 GP1 Igm Eia Test Kit.MSV · Traditional | 05/05/2000SE |
| K991802 | Bindazyme ANTI-B2 GP1 Iga Eia Test KitMSV · Traditional | 05/05/2000SE |
| K991801 | Bindazyme ANTI-B2 GP1 Igg Eia Test KitMSV · Traditional | 05/05/2000SE |
| K000701 | Human Igg Subclass Kit Use with the Beckman Image AnalyzerCFN · Traditional | 04/27/2000SE |
| K993727 | Bindazyme Anti-Dsdna Eia KitLRM · Traditional | 12/21/1999SE |
| K993612 | Bindazyme Anti-Tissue Transglutaminase Iga EiaMVM · Traditional | 12/21/1999SE |
| K981784 | Igm Minineph AntiserumCFN · Traditional | 12/21/1999SE |
| K982100 | Igg and Igg Subclass Nephelometric Diagnostic Test KitsCFN · Traditional | 12/20/1999SE |
| K981915 | Turbidimetric/Nephelometric Human Complememt Reference PreparationJJY · Traditional | 12/20/1999SE |
| K981785 | C4 Minineph AntiserumDBI · Traditional | 12/20/1999SE |
| K981783 | C3 Minineph AntiserumCZW · Traditional | 12/20/1999SE |
| K981914 | Turbidimetric/Nephelometric Human Serum Reference PreparationJJX · Traditional | 11/26/1999SE |
| K981786 | Iga Minineph AntiserumCFQ · Traditional | 11/24/1999SE |
| K992488 | Total Haemolytic Complement Rid KitDAE · Traditional | 09/17/1999SE |
| K984619 | Binding Site Bindazyme Anti-Gbm Eia Diagnostic Test KitMVJ · Traditional | 02/23/1999SE |
| K983696 | Anticardiolipin Iga Screen Eia Diagnostic Test KitMID · Traditional | 02/05/1999SE |
| K983695 | Anticardiolipin Iggam Screen Eia Diagnostic Test KitMID · Traditional | 02/05/1999SE |
| K983694 | Anticardiolipin Igm Screen Eia Diagnostic Test KitMID · Traditional | 02/05/1999SE |
| K983692 | Anticardiolipin Igg Screen Eia Diagnostic TestMID · Traditional | 02/05/1999SE |
| K984165 | Anti-Thyroglobulin Eia Diagnostic Test KitJZO · Traditional | 02/02/1999SE |
| K984163 | Anti-Tpo Eia Diagnostic Test KitJZO · Traditional | 02/02/1999SE |
| K981912 | Human Iga Subclass Bnii Combi KitCFN · Traditional | 12/04/1998SE |
| K981209 | Monkey Oesophagus Ifa Diagnostic Test KitsMVM · Traditional | 10/22/1998SE |
| K981929 | Bindazyme Antigliadin Igg/Iga Combi KitMST · Traditional | 09/03/1998SE |
| K981644 | Bindazyme Antigliadin IggMST · Traditional | 09/03/1998SE |
| K981030 | Bindazyme Anti-Mpo Enzyme Immunoassay KitMOB · Traditional | 07/20/1998SE |
| K981029 | Bindazyme ANTI-PR3 Enzyme Immunoassay KitMOB · Traditional | 07/20/1998SE |
| K973189 | Retinol Binding Protein RBP Rid KitCZS · Traditional | 09/29/1997SE |
| K965133 | Anca Combi Diagnostic Test KitMOB · Traditional | 05/21/1997SE |
| K951640 | Human Protein S Rid Test KitGGP · Traditional | 04/21/1997SE |
| K955431 | Rit Liver, Kidney, Stomach Ifa KitDBL · Traditional | 04/23/1996SE |
| K955881 | Retinol Binding Rid KitCZS · Traditional | 03/22/1996SE |
| K946070 | Human BETA-2 Microglobulin Turbindimetric KitJZG · Traditional | 01/30/1996SE |
| K946069 | Human BETA-2 Microglobulin Enhanced Nephelometric KitJZG · Traditional | 01/30/1996SE |
| K946068 | Human BETA-2 Microglobulin Enhanced Radial Immunodiffusion KitJZG · Traditional | 01/30/1996SE |
| K953207 | Human C-Reactive Protein Kit (Modification)DCK · Traditional | 08/01/1995SE |
| K941346 | Plasminogen Rid Test KitDDX · Traditional | 09/09/1994SE |
| K940422 | Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array AnalyzerDFZ · Traditional | 05/27/1994SE |
| K930987 | Crithidia Lucilliae DS DNA Kit (Diagnostic Use)KTL · Traditional | 08/10/1993SE |
| K931806 | Iga Subclass Rid Kit for Diagnostic UseCZP · Traditional | 07/16/1993SE |
| K930247 | Human A-Ds DNA Eia Kit for Diagnostic UseDHC · Traditional | 03/10/1993SE |
| K922416 | Fibrinogen Rid Test KitKQJ · Traditional | 03/09/1993SE |
| K924769 | Immunoglobulins G, a & M and Light Chain SpecificCFF · Traditional | 02/23/1993SE |
| K924767 | Immunoglobulins G, a & M Light Chain SpecificCFF · Traditional | 02/23/1993SE |
| K925118 | En Typing Cie Kit for Diagnostic UseLLL · Traditional | 02/02/1993SE |
| K924021 | Power SupplyJJN · Traditional | 01/28/1993SE |
| K924262 | Ena Screening Cie Kit for Diagnostic UseLLL · Traditional | 12/29/1992SE |
| K924020 | Electrophoresis TankJJN · Traditional | 12/28/1992SE |
| K920087 | Ige Eia Test KitDGO · Traditional | 09/14/1992SE |
| K922417 | Al-Acid Glycoprotein Rid KitLKL · Traditional | 08/20/1992SE |
| K915431 | Complement C1 Inactivator KitDBA · Traditional | 01/17/1992SE |
| K913667 | Antithrombin III Immunological NL Test KitJBQ · Traditional | 01/03/1992SE |
| K914389 | ALPHA-2 Macroglobulin Test Rid KitDEB · Traditional | 12/20/1991SE |
| K913672 | Prealbumin Immunological NL Test KitJZJ · Traditional | 12/20/1991SE |
| K913668 | Caeruloplasmin Immunological NL Test KitDDB · Traditional | 12/20/1991SE |
| K914391 | Albumin Test Rid KitDCF · Traditional | 12/10/1991SE |
| K914390 | Transferrin Rid KitDDG · Traditional | 12/09/1991SE |
| K913670 | Haptoglobin Immunological Test KitDAB · Traditional | 12/09/1991SE |
| K913666 | ALPHA-1-ANTITRYPSIN Immunological NL Test KitDEM · Traditional | 12/09/1991SE |
| K913671 | Human Igd Immunological NL Test KitCZJ · Traditional | 12/02/1991SE |
| K913131 | Human BETA-2 Microglobin En-Rid KitJZG · Traditional | 11/07/1991SE |
| K914388 | C1 Rid KitDAK · Traditional | 10/28/1991SE |
| K905633 | Human C-Reactive Protein Rid KitDCK · Traditional | 07/22/1991SE |
| K902382 | C3C and C4 Rid KitsCZW · Traditional | 09/07/1990SE |
| K895600 | Human (Igg) Subclass (Eia) KitDAS · Traditional | 11/08/1989SE |
| K881928 | Monoclonal Radial Immunodiffusion KitCFQ · Traditional | 07/08/1988SE |
| K881827 | Immunoglobulin a Test SystemCFQ · Traditional | 06/10/1988SE |
| K881174 | Rid Plate ReaderJZQ · Traditional | 06/08/1988SE |
| K881828 | Immunoglobulin M Test SystemCFQ · Traditional | 06/06/1988SE |