Device Recall ABX PENTRA Cholesterol CPref. A11A01634

  • Modelo / Serial
    All Lots
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA