Devices

CELLSEARCH Circulating Tunor Cell Kit (Epithelial)

  • 모델명 / 제조번호(시리얼번호)
    UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V  Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
  • 제품 설명
    CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) || CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
  • Manufacturer
    Menarini Silicon Biosystems
  • 1 Event

제조사

Menarini Silicon Biosystems
  • 제조사 주소
    Menarini Silicon Biosystems, 3401 Masons Mill Rd Ste 100, Huntingdon Valley PA 19006-3574
  • 제조사 모회사 (2017)
    Pharmafin Spa
  • Source
    USFDA