HER2 CISH pharmDX Kit

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14 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    20031683
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia, Qatar, Romania, Serbia, Sweden, and Turkey.
  • Description du dispositif
    Dako HER2 CISH pharmDx Kit, product code: SK 109 || Product Usage: || For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor 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
  • Modèle / numéro de série
    92789
  • Manufacturer
  • Modèle / numéro de série
    00092789, 20002057
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics - immunological products
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostic products
  • Manufacturer
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