Device Recall ImmunoCAP Allergen Ri206

  • Modèle / numéro de série
    Article number 14-5274-10, Lot number BDZ0P
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to include: MN, VA, NC, MO, SC, TX, MA, MI, FL, IL, PA, MD, UT, CO, GA, CA,
  • Description du dispositif
    ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana || It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • Société-mère du fabricant (2017)
  • Source
    USFDA