Abbott Laboratories, Inc

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Description

7 dispositivos en la base de datos

  • Modelo / Serial
    Catalog 2-95068-01 AEROSET System Software 1.02ER000 and Catalog 2-95175-01 AEROSET System Software 1.02ER000 Upgrade Kit
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China
  • Descripción del producto
    AEROSET System Software version 1.02ER000
  • Modelo / Serial
    All Serial Numbers
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and to the following foreign countries: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, Australia
  • Descripción del producto
    AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
  • Modelo / Serial
    The RS-232 Manual is not controlled by control or lot numbers.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore
  • Descripción del producto
    ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038
  • Modelo / Serial
    List Number 1G06-01, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN.
  • Descripción del producto
    The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
  • Modelo / Serial
    List number 3M74-01, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN.
  • Descripción del producto
    The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
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5 fabricantes con un nombre similar

Más información acerca de la data acá

  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 2020, Irving TX 75038
  • Source
    USFDA
  • Dirección del fabricante
    Abbott Laboratories, Inc., 4-A Crosby Drive, Bedford MA 01730
  • Source
    USFDA
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038
  • Source
    USFDA
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038-4313
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA