Clinical Chemistry Albumin BCG (AlbG)


  • 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.
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2 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    7D53-21 | 77056HW00, 80051HW00, 83030HW00
  • Description du dispositif
    IVD: Albumin kit
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 77056HW00; 80051HW00; 83030HW00 Exp dates: 04/15/2011, 07/15/2011, and 10/10/2011, respectively.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US nationwide and internationally to Germany, Hong Kong, Australia, New Zealand, Trinidad/Tobago, and Jamaica. No dsitribution of Canada or Mexica.
  • Description du dispositif
    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 || Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX || The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
  • Manufacturer