Alere San Diego Inc. DBA Immunalysis Corporation

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Description

  • Dirección del fabricante
    Alere San Diego Inc. DBA Immunalysis Corporation, 829 Towne Center Dr, Pomona CA 91767-5901
  • 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
    USFDA
  • 1 Event

Un dispositivo en la base de datos

  • Modelo / Serial
    Part Number: 3006-5, Lot Number: EK16135
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV
  • Descripción del producto
    lmmunalysis EDDP Urine Control Set 1 || The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.