The Binding Site Group , Ltd.
The Binding Site Group , Ltd. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2025, with 29 FDA device recalls on record.
Top product codes for The Binding Site Group , Ltd.
FDA recalls by The Binding Site Group , Ltd.
10 most recent of 29- Z-2362-2026 — Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.
- Z-0274-2022 — Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
- Z-2030-2021 — FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
- Z-0943-2021 — Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
- Z-2071-2020 — The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.
- Z-1500-2020 — Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
- Z-2110-2020 — Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
- Z-1327-2020 — OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
- Z-1619-2020 — C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
- Z-0671-2020 — Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by The Binding Site Group , Ltd.
- K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
- K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
- K192116 — Human IgA liquid reagent kit for Use on SPAPlus
- K191985 — Optilite IgA Kit
- K191635 — Optilite IgM Kit
- K191465 — Human IgM Kit for use on SPAPlus
- K190686 — Optilite IgM CSF Kit
- K183151 — Optilite IgA CSF Kit
- K180099 — Optilite High Sensitivity C-Reactive Protein Kit
- K173732 — Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
- K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
- K172613 — Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
- K162263 — Optilite Rheumatoid Factor Kit
- K160070 — Rheumatoid Factor (RF) Kit for use on SPAPLUS
- K161854 — Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
- K153560 — Optilite Low Level Albumin Kit
- K160819 — Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
- K152389 — Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
- K151759 — Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
- K150412 — Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
- K150658 — Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
- K150526 — Optilite IgG4 Kit
- K143118 — Human Microalbumin kit for use on SPAPLUS
- K142735 — The Optilite IgG3 kit
- K140686 — HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
- K141100 — OPTILITE C1 INACTIVATOR KIT
- K140396 — FREELITE HUMAN LAMBDA FREE KIT
- K140664 — HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
- K123256 — HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
- K121045 — HUMAN ALBUMIN CSF KIT
- K122965 — HUMAN CAERULOPLASMIN KIT
- K120901 — HUMAN IGA CSF KIT FOR USE ON SPAPLUS
- K120749 — HUMAN IGG CSF KIT
- K120750 — HUMAN IGM CSF KIT
- K122304 — HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
- K120056 — HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
- K113823 — HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
- K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS
- K122066 — HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
- K113349 — HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
- K100588 — HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
- K100179 — SPAPLUS
- K082823 — HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
Data sourced from openFDA. This site is unofficial and independent of the FDA.