Device Recall PROTrac II Tacrolimus ELISA kit

  • Modèle / numéro de série
    131716, 131716A, 131716B, 131716C, 131716D, 131716E,  131717.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
  • Description du dispositif
    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. || Product Usage: || The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Société-mère du fabricant (2017)
  • Source
    USFDA