Device Recall ABX PENTRA Triglycerides CPref. A11A01640

  • 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 Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
  • Manufacturer
  • 1 Event

Manufacturer

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