ARCHITECT Cyclosporine

  • Model / Serial
    lots 95098M500 exp 12/21/2011; 96143M500 exp 01/20/2012; 96142M500 exp 01/20/2012; 01107M500 exp 02/24/2011; 02079M500 exp 02/24/2012; 03182M500 exp 05/19/2012; 05533M500 exp 05/19/2012; 04069M500 exp 06/02/2012; 06525M500 exp 06/02/2012; 05014M500 exp 06/23/2012; 07011M500 exp 06/23/2012
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.
  • Product Description
    ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25. || The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    1L75-25 | All lots
  • Product Description
    IVD: Cyclosporine specific
  • Manufacturer
  • Model / Serial
  • Product Description
    ARCHITECT Cyclosporine Reagents
  • Manufacturer