Device Recall Euro Diagnostica DIASTAT ANA (antinuclear antibody)

  • Modèle / numéro de série
    Lot: TS 2076
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    MN, NE, TX
  • Description du dispositif
    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA || DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Euro Diagnostica AB, Box 50117, Lundavagen 151, Malmo Sweden
  • Société-mère du fabricant (2017)
  • Source
    USFDA