Vitros Performance Verifier II


  • 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
    Lot K4852, Expiration 22 Feb 2018
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
  • Description du dispositif
    VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. || Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
  • Modèle / numéro de série
    VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)Product Code (Unique Identifier): 8231474 (10758750004577)Lot Number: K4852Expiry: 22 Feb 2018
  • Manufacturer