Device Recall ABX PENTRA Glucose PAP CPref. A11A01668

  • Modèle / numéro de série
    All Lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.
  • Description du dispositif
    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Société-mère du fabricant (2017)
  • Source
    USFDA