Clinical Chemistry Total Bilirubin

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    HPRA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
  • Model / Serial
    List Numbers: 6L45-20, 6L45-40 Lot Numbers: 64047HW00, 64048HW00, 65084HW00, 65088HW00, 69001HW00, 69002HW00, 72016HW00, 73038HW00, 73057HW00, 75036HW00, 76023HW00, 77014HW00, 69025HW00, 73015HW00, 76038HW00, 77015HW00.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Guatemala, Chile, Brazil, Canada, Germany, Hong Kong, Thailand, Puerto Rico, Australia, New Zealand, Trinidad & Tobago, Bermuda, Curacao, Cayman Island, and Jamaica.
  • Product Description
    Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. || Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates.
  • Manufacturer