Cholestech LDX Lipid Controls


  • Dirección del fabricante
    Biosite Inc Dba Innovacon 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

2 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    10-982, 10-983 | SV0146, SC0146
  • Descripción del producto
    IVD: Assayed multicomponent serum kit, normal
  • Manufacturer
  • Modelo / Serial
    Lot # SC0146
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.
  • Descripción del producto
    Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. || Assayed quality control material for use with the Cholestech LDX System.
  • Manufacturer