Device Recall Cell Marque CD7 (MRQ12);

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • Société-mère du fabricant (2017)
  • Source
    USFDA