Device Recall CellTracks Auto Prep System

  • 모델명 / 제조번호(시리얼번호)
    Product code 9541
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.
  • 제품 설명
    CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD || Veridex, LLC || a Johnson & Johnson Company || Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Veridex, LLC, 1001 US Route 202, Raritan NJ 08869-0606
  • 제조사 모회사 (2017)
  • Source
    USFDA