Accelerator a3600

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.
  • Représentant du fabricant
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA

10 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Concerning the centrifugation module reference 06P37.
  • Description du dispositif
    Designed to automate pre-analytical and post-analytical processing, in order to automate the processing of samples in the laboratory
  • Manufacturer
  • Modèle / numéro de série
    Serial Numbers:  Accelerator a3600 -  ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214  FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181  Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095  Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributors in 2 states: NY and IL.
  • Description du dispositif
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
  • Manufacturer
  • Modèle / numéro de série
  • Manufacturer
5 en plus