CHOLESTECH LDX ANALYZER

  • Modèle / numéro de série
    Model Catalog: 88769 (Lot serial: C2510A); Model Catalog: 88769 (Lot serial: C2510)
  • Description du dispositif
    Alere Cholestech LDX Multianalyte Control 2 vial set
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    OTTAWA
  • 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
    HC

6 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostic products
  • Manufacturer
  • Modèle / numéro de série
    Model Number: 10-228 and 14-535 Lot Number: 332994
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - U.S Nationwide in the states of: TN, MA, GA, OK, VA, FL, TN, MO, AL, TX, IL, NY, VT, RI, KY, WI, AL, NC, LA, SD, TX, VA, MI, MN, IN, IA, CA, AR, PA, HI, WV, KS, CO, CT, UT and the countries of Japan, England, Canada
  • Description du dispositif
    LDX Optical Check Cassettes (OCC) || Model Number: 10-228 and 14-535 || Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. || Product Usage: || The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.
  • Manufacturer
  • Modèle / numéro de série
    14-875 | v.3.30
  • Description du dispositif
    IVD: Clinical chemistry analyser
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 10-983 (Lot serial: SC0146)
  • Description du dispositif
    CHOLESTECH LDX ANALYZER
  • Manufacturer
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