Siemens Healthcare Diagnostics, Inc.

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Description

107 dispositivos en la base de datos

  • Modelo / Serial
    Device Listing Number: D011448 (Kc110) and D244577 (KC110B) Lot numbers: MGM081 and MGM082
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide) Internationally to Australia, Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Qatar, Saudi Arabia, South Korea, Slovakia, Slovenia, Spain, and Switzerland.
  • Descripción del producto
    Dimension Vista Chemistry 1 Calibrator || The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System
  • Modelo / Serial
    CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution in the states of: MN, NJ, and NV.
  • Descripción del producto
    Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 || The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
  • Modelo / Serial
    Material numbers 10284473, 10488224, 10444801, and 10444802.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) Distribution including Puerto Rico.
  • Descripción del producto
    User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower || User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
  • Modelo / Serial
    Lot Number - 3DD007
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution: US Nationwide including Puerto Rico
  • Descripción del producto
    Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. || The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
  • Modelo / Serial
    lot 13064MA, expiration 2014-03-05
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.
  • Descripción del producto
    Siemens Dimension Vista Homocysteine Flex Reagent Cartridge || The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
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Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Source
    MHRB
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, Po Box 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Empresa matriz del fabricante (2017)
  • Source
    AEMPSVFOI
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
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