ARCHITECT

  • Modèle / numéro de série
    ARCHITECT c4000 Cuvette Segment 02P75-01 Not applicable ARCHITECT c8000 Cuvette Segment 01G46-01 Not applicable ARCHITECT c16000 Cuvette Segment 09D32-05 Not applicable
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    AMPMDRS

695 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    List number 08G98-07 for Conventional Units; List number 04J62-07 for SI Units.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand
  • Description du dispositif
    ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
  • Manufacturer
  • Modèle / numéro de série
    All lots/serial numbers.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide. Product distributed nationwide to direct accounts (including gov''t accounts) in: AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WY. Foreign distribution to the following countries: Argentina, Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Grand Cayman, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Puerto Rico, Singapore, Thailand, Trinidad, Uruquay and Venezuela.
  • Description du dispositif
    ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX.
  • Manufacturer
  • Modèle / numéro de série
    list 2K41-20, lot 95567G005, exp 6-30-2006
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Canada, Australia, Germany and Taiwan
  • Description du dispositif
    ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
  • Modèle / numéro de série
    lot numbers 33079M200, 33079M201
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Canada, Germany and Australia
  • Description du dispositif
    ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
  • Modèle / numéro de série
    list numbers 6C11-20, 6C11-25 and 6C11-30; all lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Canada, Germany, Uruguay, Japan, Singapore, Hong Kong, South Korea, Australia and New Zealand
  • Description du dispositif
    ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
690 en plus