Devices

Device Recall AdvanDx GramNegative QuickFISH BC

  • Modèle / numéro de série
    Lot codes US: 04813C, 7413, 08113 exp. 2013-12  Lot codes OUS: 03113A 04213A 04813B
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
  • Description du dispositif
    AdvanDx Gram-Negative QuickFISH BC. || In-Vitro Diagnostic for the identification of Enterobacteriacae || Catalog Number: QFGNRBC1-25 || Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
  • Manufacturer
    AdvanDx, Inc.
  • 1 Event

Fabricant

AdvanDx, Inc.
  • Adresse du fabricant
    AdvanDx, Inc., 10a Roessler Rd, Woburn MA 01801-6208
  • Société-mère du fabricant (2017)
    Advandx, Inc.
  • Source
    USFDA