Device Recall IDkit:HP" Two Test System

  • Modelo / Serial
    Reorder No. AC00028, Lot numbers: 11-071, 11-0561, 10-00018 and 10-00017.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution (USA) - including the states of: FL, IL, LA, MA, MS, NY, TN, TX and VA.
  • Descripción del producto
    IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA || Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Exalenz Bioscience Ltd, Hamaayan 4, Modiin Israel
  • Empresa matriz del fabricante (2017)
  • Source