EnVision Model Number K4008

  • Modèle / numéro de série
    K4008: Lots 085146 & 065143
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
  • Description du dispositif
    EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4008
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Dakocytomation California Inc, 6392 Via Real, Carpinteria CA 93013-2921
  • Source
    USFDA