Abbott Point of Care

14 dispositifs dans la base de données

  • Modèle / numéro de série
    04J50-01, 04J50-02, 03P89-24 | R13149A, R13151, R13151A, lots from C13139 to C13270A
  • Description du dispositif
    IVD: Prothrombin time kit
  • Modèle / numéro de série
    O4J50·01, O4J50·02, 031'89·24 | PTf1NR 10lS beginning with RI I or RI2
  • Description du dispositif
    IVD: Prothrombin time kit
  • Modèle / numéro de série
    06F15-03, 06F15-04, 03P90-25, 600-9009-25
  • Description du dispositif
    IVD: Troponin kit
  • Modèle / numéro de série
    03P90-25, 06F15-03, 06F15-04, 600-9009-25 | Lots beginning with letter "T", See FSN
  • Description du dispositif
    IVD: Troponin control
  • Modèle / numéro de série
    07G01-0l, 07G01-02, 03P86-25, 600-9006-25
  • Description du dispositif
    IVD: Activated whole blood clotting time kit
9 en plus

20 fabricants avec un nom similaire

En savoir plus sur les données ici

  • 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
    NZMMDSA
  • Adresse du fabricant
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 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
  • Adresse du fabricant
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520-1407
  • Source
    USFDA
  • 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
    AEMPSVFOI
15 en plus