Device Recall iView DAB Detection Kit

  • Modèle / numéro de série
    Lot number: B01057A
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Oro Valley AZ 85755-1962
  • Société-mère du fabricant (2017)
  • Source
    USFDA