HER2 CISH pharmDx Kit

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14 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    92789
  • Manufacturer
  • Modèle / numéro de série
    00092789, 20002057
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics - microbiological products
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics - immunological products
  • Manufacturer
  • Modèle / numéro de série
    Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and in the country of Chile.
  • Description du dispositif
    Product Name: HER2 CISH pharmDx Kit || Catalog/Model number: SK109, lot 20000910 || Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
  • Manufacturer
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