Device Recall ABX PENTRA Uric Acid CPref. A11A01670

  • Modèle / numéro de série
    All Lots
  • Classification du dispositif
  • Classe de dispositif
    1
  • 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 Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).
  • Manufacturer
  • 1 Event

Fabricant

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