Architect LH reagent

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
    BAM

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
  • Description du dispositif
    in-vitro_medical_device
  • Manufacturer
  • Modèle / numéro de série
    lot numbers 33198M200 and 41861M100, 33198M201, and 33871M100. All lots expire 6/16/2007.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.
  • Description du dispositif
    ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
  • Manufacturer