Device Recall Cell Marque CD7 (MRQ12);

  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers: 107M-14 (0.1 ml concentrate); 107M-15 (0.5 ml concentrate); 107M-16 (1.0 ml concentrate); 107M-17 - (1.0 ml predilute) and 107M-18 (7.0 ml predilute). Product lot # 8109, Exp 2012-09.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Greece, Turkey, Italy, The Netherlands, Spain, Portugal, France, Israel, S. Korea, Pakistan, Morocco, Russia and Brazil.
  • 제품 설명
    Cell Marque CD7 (MRQ-12); || Mouse Monoclonal Antibody, || Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label. || Cell Marque, Rocklin, CA 95677, || intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in section of formalin fixed, paraffin embedded tissue section using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist or physician.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • 제조사 모회사 (2017)
  • Source
    USFDA