Device Recall E.faecalis/OE PNA Fish

  • Modelo / Serial
    Catalog number KT003
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    AdvanDx, Inc., 10a Roessler Rd, Woburn MA 01801-6208
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA