Device Recall PTS Panels Creatinine test strips.

  • Modèle / numéro de série
    Cat No. 1720; and Lot number F103
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
  • Description du dispositif
    PTS Panels Creatinine test strips. || PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Polymer Technology Systems, Inc., 7736 Zionsville Rd, Indianapolis IN 46268-2175
  • Société-mère du fabricant (2017)
  • Source
    USFDA