HER2 CISH PHARMDX KIT

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: SK109 (Lot serial: 20031665)
  • 제품 설명
    HER2 CISH PHARMDX KIT;HER2 CISH PHarmdx kit
  • Manufacturer
  • 1 Event

제조사

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 14 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    In-vitro diagnostic products
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog/Model number: SK109, lot 20000910. Shelf Life: 10 months when stored at 2-8 ¿C. Expiration Date: 2014 June 30.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide and in the country of Chile.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    SK109 | 92789
  • 제품 설명
    IVD: DNA-probe, human chromosome
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Code SK109 | 20031665
  • 제품 설명
    IVD: DNA-probe, human chromosome
  • Manufacturer
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