HER2 CISH

  • Model / Serial
  • Product Description
    Withdrawal of Lot 20031665 of the HER2 CISH Medical Device PharmDx Kit.
  • Manufacturer
  • 1 Event

Manufacturer

23 devices with a similar name

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  • Model / Serial
    Lot 1029335, Exp. August 31, 2012
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the states of CA and NV and the countries of: Canada, Venezuela, and the UK.
  • Product Description
    SPOT-Light" HER2 CISH¿ Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** || 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
  • Model / Serial
    Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and in the country of Chile.
  • Product Description
    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
  • Model / Serial
    SK109 | 92789
  • Product Description
    IVD: DNA-probe, human chromosome
  • Manufacturer
  • Model / Serial
    Code SK109 | 20031665
  • Product Description
    IVD: DNA-probe, human chromosome
  • Manufacturer
  • Model / Serial
    Model Catalog: SK109 (Lot serial: 20031665)
  • Product Description
    HER2 CISH PHARMDX KIT;HER2 CISH PHarmdx kit
  • Manufacturer
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