Device Recall E.faecalis/OE PNA Fish

  • Modèle / numéro de série
    Catalog number KT003
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
  • Description du dispositif
    E.faecalis/OE PNA FISH || Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media
  • Manufacturer
  • 1 Event

Fabricant

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