Device Recall SPOTLight" HER2 CISH Kit

  • Modèle / numéro de série
    Lot 1029335, Exp. August 31, 2012
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK.
  • Description du dispositif
    SPOT-Light" HER2 CISH¿ Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704*** || Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin¿ (trastuzumab) treatment is being considered.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Life Technologies Corporation, 7305 Executive Way, Frederick MD 21704-8354
  • Société-mère du fabricant (2017)
  • Source