IMx Sirolimus Reagent Pack


  • 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.
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  • Modelo / Serial
    list 5C91-21, lots 053389, 053457, 063650, 063973, 064459, 064772, 064750, 065076
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide, including USA, Puerto Rico, Poland, Croatia, Latvia, Estonia, Serbia & Montenegro, Japan, Turkey, Singapore, China, India, Taiwan, Thailand, South Africa, South Korea, Australia, New Zealand, Norway, Italy, Portugal, Spain, Greece, Panama, Hungary, Slovakia, Russia, Romania, Cyprus, Germany, Lithuania, Saudi Arabia, Jordan, Israel, Lebanon, Kuwait, Oman, Qatar, UAE, Egypt, Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Argentina, Brazil, El Salvador, Canada, Ireland, United Kingdom, Sweden, Netherlands, Belgium, France, Austria, Czech Republic, and Switzerland
  • Descripción del producto
    IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer