Cholestech LDX Lipid Controls

  • Modèle / numéro de série
    Lot # SV0146
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.
  • Description du dispositif
    Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982. || Assayed quality control material for use with the Cholestech LDX System.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biosite Inc Dba Innovacon Inc., 9975 Summers Ridge Rd, San Diego CA 92121
  • 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

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    10-982, 10-983 | SV0146, SC0146
  • Description du dispositif
    IVD: Assayed multicomponent serum kit, normal
  • Manufacturer
  • Modèle / numéro de série
    Lot # SC0146
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Canada, Great Britain, India, Italy, Mexico, Norway, Puerto Rico, South Korea, Spain, Switzerland, and Trinidad & Tobago.
  • Description du dispositif
    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