Alinity i Processing Module

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

16 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    ALINITY CI-SERIES MODULE, all serials.
  • Description du dispositif
    It is a fully automated immunoassay system that allows random and continuous access, as well as priority processing and automatic re-analysis using chemoluminescent micro-particle immunoassay technology. CMIA technology is used to determine the presence of antigens, antibodies and analytes in samples. The scalable design of the ALINITY I allows one or more sample processing modules, in multiple configurations, with a system control module to physically join together to form a single workstation.
  • Manufacturer
  • Modèle / numéro de série
  • Manufacturer
    N/A
  • Modèle / numéro de série
  • Description du dispositif
    ivd
  • Manufacturer
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