BEUDAMED
    10 results · 7ms · Sources: EU EUDAMED, US FDA

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    BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.

    FDA Enforcement
    Class III ·Terminated·BD Biosciences, Systems & Reagents·July 22, 2015

    BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

    FDA Enforcement
    Class III ·Terminated·BD Biosciences, Systems & Reagents·August 20, 2014

    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·August 17, 2016

    BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·February 13, 2019

    FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·January 20, 2016

    BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·April 20, 2016

    BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·November 4, 2015

    CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·September 30, 2015

    BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·March 2, 2016

    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

    FDA Enforcement
    Class III ·Terminated·Becton, Dickinson and Company, BD Biosciences·August 8, 2018