Device Recall Triage Drugs of Abuse Panel

Fabricante

  • Dirección del fabricante
    Biosite Inc, 9975 Summers Ridge Rd, San Diego CA 92121
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lots 235991 and 238928.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US and to Canada.
  • Descripción del producto
    Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 || An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine.
  • Manufacturer