Device Recall iView DAB Detection Kit

  • Modelo / Serial
    Lot number: B01057A
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.
  • Descripción del producto
    iView DAB Detection Kit, Part number: 760-091 || (05266157001) || This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Oro Valley AZ 85755-1962
  • Empresa matriz del fabricante (2017)
  • Source