Abbott Laboratories, Inc

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Description

11 dispositivos en la base de datos

  • Modelo / Serial
    ISR03967, ISR04737, ISR01461, ISR01998, ISR01964, ISR02446, ISR02751, ISR02781, ISR05266, ISR04520, ISR01460, ISR01442, ISR01988, ISR03034, ISR01194, ISR01583, ISR01955, ISR02437, ISR03144, ISR03352, ISR04369, ISR02360, ISR02361, ISR02842, ISR03495, ISR03756, ISR04244, ISR04420, ISR05155, ISR05240, ISR05242, ISR05433, ISR05671, ISR05883, ISR05946, ISR06050, ISR06054, ISR06837, ISR06864, ISR01696, ISR02073, ISR02264, ISR02269, ISR02999, ISR03668, ISR03901, ISR04053, ISR04165, ISR04388, ISR04586, ISR04619, ISR04770, ISR04773, ISR04775, ISR04801, ISR04996, ISR05202, ISR05662, ISR05732, ISR05751, ISR06406, ISR06592, ISR07108, ISR07240, ISR07741
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan
  • Descripción del producto
    ARCHITECT i2000SR System || The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
  • Modelo / Serial
    All shipped out to this date
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
  • Descripción del producto
    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 || The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
  • Modelo / Serial
    Lot Numbers 52803UN12, 62299UN12, and 85773UN12
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Internationally distributed to Argentina, Australia, Austria, Bahamas, Brunei, Canada, Chile, Curacao, Denmark, France, Germany, Greece, Ireland, Italy, Lebanon, Mexico, Netherlands, Norway, Oman, Paraguay, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    Clinical Chemistry Phenobarbital, list number 1E08
  • Modelo / Serial
    Serial numbers - 125589-1-2, 125589-1-4
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution to US, Canada, France, and Germany.
  • Descripción del producto
    Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
  • Modelo / Serial
    c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution to US, Canada, France, and Germany.
  • Descripción del producto
    ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
6 más

5 fabricantes con un nombre similar

Más información acerca de la data acá

  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 2020, Irving TX 75038
  • Source
    USFDA
  • Dirección del fabricante
    Abbott Laboratories, Inc., 4-A Crosby Drive, Bedford MA 01730
  • Source
    USFDA
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75015-2020
  • Source
    USFDA
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038
  • Source
    USFDA
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038-4313
  • 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