Sysmex America, Inc.

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Description

6 dispositivos en la base de datos

  • Modelo / Serial
    Software versions 1.0, 1.01, 1.1.1, 1.1.2
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of Canada.
  • Descripción del producto
    The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.
  • Modelo / Serial
    catalog ##053-2311-4, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including Puerto Rico.
  • Descripción del producto
    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 || The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Modelo / Serial
    catalog #063-7591-7, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including Puerto Rico.
  • Descripción del producto
    Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 || The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
  • Modelo / Serial
    catalog #983-1341-1, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including Puerto Rico.
  • Descripción del producto
    Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 || The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.
  • Modelo / Serial
    Catalog number SIM-220A, lot numbers C9010, C9011, C9013, C9014, C9015, C9016 and C9017
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.
  • Descripción del producto
    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. || The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
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