HbA1c Flex(R) reagent cartridge

  • Modèle / numéro de série
    Catalog number K3105A (Siemens Material Number 10470481) - Lot numbers 12072AA, exp. 2/9/13: 12086AA, exp. 2/23/13:12107AA, exp. 3/16/13; 12128AA, exp. 4/6/13; 12150AA, exp. 4/28/13; 12191AA, exp. 6/8/13; 12212AA, exp. 6/29/13; 12226AA, exp. 7/13/13; 12248AA, exp. 8/4/13; 12261AA, exp. 8/17/13; 12282AA, exp. 9/7/13; 12303AA, exp. 9/28/13.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
  • Description du dispositif
    HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. || Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Société-mère du fabricant (2017)
  • Source
    USFDA