Tosoh

  • Modelo / Serial
    Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.
  • Descripción del producto
    Tosoh brand Glycohemoglobin A1c Controls I & II, || Catalog Number: 992133; || Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Tosoh Bioscience, Inc., 347 Oyster Point Blvd Ste 201, South San Francisco CA 94080-1913
  • Source
    USFDA

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Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    The TOSOH G7 HPLC automated system analyzer is a fully automated high-performance liquid chromatography instrument that rapidly and precisely separates hemoglobins found naturally in the blood. Glycosylated hemoglobins and other components of hemoglobin are extracted depending on the charge of the molecule in relation to an incremental gradient that pass through a non-porous cationic column. In the mode of HbA1c variant analysis, the predetermined windows are configured in the software to detect the presence of HbA1a, HbA1b, HbF, labile HbA1c (la1c), HbA1c (sa1c), and a0. The reagents that are used with the TOSOH G7 analyzers have a respective health record.
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