Abbott Laboratories, Inc

7 devices in the database

  • Model / Serial
    All Serial Numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to the following foreign locations: Mexico, Viet Nam, Venezuela, Columbia, Argentina, Chile, Japan, Austria, Denmark, France, Israel, Norway, Saudi Arabia, Spain, Turkey, India, Phillippines, Brazil, Puerto Rico, Dominicam Republic, Canada, Germany, Taiwan, Thailand, Belgium, Egypt, Greece, Italy, Poland, South Africa, Sweden, United Arab Emirates, Malaysia, Singapore, Hong Kong, Australia, New Zealand, China, Uruguay, Korea, England, Czech Republic, Finland, Hungary, Netherlands, Portugal, Eastern Europe, Switzerland, Central America, and Pakistan
  • Product Description
    AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Texas
  • Model / Serial
    All Serial numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    States of Virginia, Illinois, New York, Texas, Oklahoma, Pennsylvania, ILlinois, Michigan, California, New Hampshire, Ohio, Florida, Maryland, Nevada, Georgia, Minnesota, Colorado, Arizona, Missouri, Louisiana, Oregon, Wisconsin, Hawaii, Connecticut, New Hampshire, Massachusetts, Washington, South Carolina, Mississippi, Alabama, and Tennessee, and the following foreign countries: Austria, Denmark, Germany, Italy, Poland, South Africa, Sweden, England, Colombia, Australia, Japan, New Zealand, Belgium, Finland, Greece, Netherlands, Portugal, Romania, Turkey, Canada, Mexico, Hong Kong, Korea, Taiwan, Czech Republic, France, Israel, Norway, Saudi Arabia, Spain, United Arab Emirates, Brazil, Venezuela, India, Malaysia, and Thailand.
  • Product Description
    ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
  • Model / Serial
    List Number 1G06-01, all serial numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
  • Model / Serial
    List number 3M74-01, all serial numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
  • Model / Serial
    The RS-232 Manual is not controlled by control or lot numbers.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore
  • Product Description
    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
2 more

5 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 2020, Irving TX 75038
  • Source
    USFDA
  • Manufacturer Address
    Abbott Laboratories, Inc., 4-A Crosby Drive, Bedford MA 01730
  • Source
    USFDA
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038
  • Source
    USFDA
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038-4313
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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