Veridex, LLC

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Description

9 dispositivos en la base de datos

  • Modelo / Serial
    Lot C512; Product code 7900003
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.
  • Descripción del producto
    Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
  • Modelo / Serial
    Product code 9541
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.
  • Descripción del producto
    CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD || Veridex, LLC || a Johnson & Johnson Company || Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
  • Modelo / Serial
    CellTracks AutoPrep: 9541, Waste Bottle CT4256.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008.
  • Modelo / Serial
    First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555  Serial numbers:   CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide
  • Descripción del producto
    CELLTRACKS ANALYZER II¿ (Product Code 9555) || Product Usage: || The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
  • Modelo / Serial
    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below). Product Code: CT1476B (9555).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
  • Descripción del producto
    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. || Product Usage: || The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.
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  • Dirección del fabricante
    Veridex, LLC, 33 Technology Dr, Warren NJ 07059-5148
  • Source
    USFDA