Abbott Laboratories HPD/ADD/GPRD

40 devices in the database

  • Model / Serial
    list 7A24-20, lot 01687M300
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Michigan, North Carolina, Ohio, Tennessee, Wisconsin, Georgia, Illinois, Kentucky, Massachusetts and Texas, and internationally to Columbia, Peru, Uruguay, Brazil, San Salvador, Canada, Germany, Singapore, Korea and Honduras
  • Product Description
    IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
  • Model / Serial
    list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.
  • Product Description
    AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
  • Model / Serial
    List 7C18-20, 4 x 100 test kit, lots 07779M300, exp 06/19/2004 and 95551M300, exp 01/26/2004; and list 7C18-25, 100 test kit, lot 07779M301, exp 06/19/2004
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Canada, Japan, Australia, New Zealand, Germany and England
  • Product Description
    Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
  • Model / Serial
    All lot numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Guatemala, Venezuela, Columbia, Peru, Chile, Australia, Panama, Argentina, Puerto Rico, Dominican Republic, Canada, Germany, New Zealand, England, Japan, Singapore, Thailand, Korea and Costa Rica.
  • Product Description
    IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
  • Model / Serial
    Reagent List 9515-60, lot 03492Q100 and Reagent List 9515-85, lot 04530Q100 that contain insert item number 69-5121/R4
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.
  • Product Description
    Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
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One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA