Device Recall VIDAS Estradiol II (E2 II)

  • Modèle / numéro de série
    Lots 1005081700, 1005172850 & 1005359170
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
  • Description du dispositif
    VIDAS Estradiol II, Ref 30431-01, 60 tests || The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Société-mère du fabricant (2017)
  • Source
    USFDA