Device Recall CD99

  • Modèle / numéro de série
    Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.
  • Description du dispositif
    CD99 || Catalog number PM008 AA; || For In Vitro Diagnostic Use. || Product Usage: || Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biocare Medical, LLC, 4040 Pike Ln, Concord CA 94520-1227
  • Société-mère du fabricant (2017)
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Number 1113202A, Exp date: 2014-04.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.
  • Description du dispositif
    Cell Marque antibody CD99 (H036-1.1) || Mouse Monoclonal Antibody. || Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 || The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections 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 of physician.
  • Manufacturer