Device Recall ABX PENTRA Uric Acid CPref. A11A01670

  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Manufacturer Parent Company (2017)
  • Source
    USFDA