Axis-Shield Diagnostics, Ltd.

  • Adresse du fabricant
    Axis-Shield Diagnostics, Ltd., The Technology Park, Luna Place, Dundee United Kingdom
  • 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
    USFDA
  • 1 Event

Un dispositif médical dans la base de données

  • Modèle / numéro de série
    Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
  • Description du dispositif
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) || Product Usage: || For in-vitro quantitative determination of total homocysteine in human plasma or serum.

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  • Adresse du fabricant
    Axis-Shield Diagnostics, Ltd., The Technology Park, Luna Place, Dundee, Scotland United Kingdom
  • Source
    USFDA