Device Recall LIFECODES PF4 Enhanced assay

  • Modèle / numéro de série
    Kit Lot Number 3000389
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
  • Description du dispositif
    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 || GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
  • Source
    USFDA