Bio-Rad Laboratories Inc

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Description

31 dispositivos en la base de datos

  • Modelo / Serial
    Product code LCP,expiration dates between 2011-07-12 and 2011-07-26. Kit lot numbers (I):072T97, 072T98, 072T100, (II): 074P75, 074P73, Device lot numbers 131Q203 38864, 131Q204 39008, 131Q206 39088
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Philippines.
  • Descripción del producto
    in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA. || The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall glycemic control.
  • Modelo / Serial
    Lot No. 70291520.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Hong Kong, and New Zealand.
  • Descripción del producto
    Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. || Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
  • Modelo / Serial
    version 4.0 software
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA || Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
  • Modelo / Serial
    Catalog numbers 281-0001EX, 281-0001, and 281-0001ST, all product manufactured sinc 2007-09-20.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed to Bio-Rad's US subsidiary, along with 18 other distribution subsidiaries outside the US. These distributed further to other consignees. POroduct was distributed to Mexico, Korea, Singapore, Italy, South Africa, India, Australia, Spain, Greece, France, Thailand, Germany, New Zealand, China, Hong Kong, Portugal, Czech Republic, United Kingdom, Canada, Russia, Netherlands, Taiwan, Austria, Denmark, Israel, Finland and Belgium as well as to other African and Latin American countries.
  • Descripción del producto
    in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK || The in2it (I) and (II) is an affinity chromatography method and is intended for the in-vitro quantitative determination of A1c in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood Glucose levels of known diabetics, for professional use as an indicator of overall glycemic control. The in2it (I) assay is intended for use in a physicians/doctors' office, the in2it (II) is intended for home use. The in2it Self Test system in intended for testing blood taken from a fingerstick. The test system is for self testing and for in-vitro diagnostic use only (not to be swallowed). The system shows how good glucose control has been over a two to three month period. The test system is the same as the test that has been CE marked for use in a clinical laboratory. The instructions for use have been changed with suggestions from people with diabetes. A patient study was conducted where untrained users ran their own blood tests and produced results which were as accurate as results obtained by trained users.
  • Modelo / Serial
    Lot Numbers: 70200185.   Lot Nos.: 70200185, AA00190
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Italy.
  • Descripción del producto
    Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains the update kit CD-ROM, Model/Catalog No.: 270-2423, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA. || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).
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Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Representante del fabricante
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA
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