Abbott Diagnostic International, Ltd.

6 devices in the database

  • Model / Serial
    List # 7A65-20 Lots # 53190Q100 Exp Date 04/12/08 and Lot # 53190Q101 Exp Date 04/12/08
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii and Puerto Rico, an countries of Canada, Mexico, Guatemala, Germany, Australia, Japan, Singapore, Hong Kong, Taiwan, South Korea, and New Zeland.
  • Product Description
    Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer. Abbott Laboratories, Abbott Park, IL 60064
  • Model / Serial
    List # 9512-85 // Lot # 51189Q100 Exp Date 09/17/08
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii and Puerto Rico, an countries of Canada, Mexico, Guatemala, Germany, Australia, Japan, Singapore, Hong Kong, Taiwan, South Korea, and New Zeland.
  • Product Description
    Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064
  • Model / Serial
    List # 9512-60 / Lot # 51187Q100 Exp Date: 09/17/08
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii and Puerto Rico, an countries of Canada, Mexico, Guatemala, Germany, Australia, Japan, Singapore, Hong Kong, Taiwan, South Korea, and New Zeland.
  • Product Description
    Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064
  • Model / Serial
    Lot 61275Q100, exp. date: 09/09/08; Lot 58167Q100, exp. date: 08/30/08; Lot 56039Q101, exp. date: 07/13/08; and Lot 56039Q100, exp. date: 07/13/08.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, AZ, AR, CA, CT, FL, GA, IL, KS, MD, MA, MI, MN, MS, MO, NV, NJ, NY, ND, OK, OR, PA, RI, TX, VA, WA, Hawaii, and Puerto Rico, and countries of Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Chile, Uruguay, Argentina, Puerto Rico, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand, Curacao, and Panama.
  • Product Description
    AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) || The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.
  • Model / Serial
    Lot 50082Q100 Exp Date 02/23/2008, Lot 52369Q100 Exp Date 04/20/2008, Lot # 53620Q100 Exp Date 06/26/2008 and Lot # 57518Q100 Exp Date 09/07/2008
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AZ, CA, CO, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, WA, WI, WV, and WY, and Puerto Rico, and countries of Canada, Mexico, Brazil, Chile, Germany, Japan, and Hong Kong.
  • Product Description
    AxSYM Ultrasensitive hTSH II Master Calibrators || Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
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2 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Abbott Diagnostic International, Ltd., 30 Bo Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA
  • Manufacturer Address
    Abbott Diagnostic International, Ltd., Carr 2 Km 58.0, Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA