Device Recall International Technidyne Corporation

  • Modelo / Serial
    E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
  • Descripción del producto
    Hemochron Jr. Citrate APTT Cuvette || 510(k) K014008 || A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    ITC-Nexus Dx, 23 Nevsky St, Edison NJ 08820-2425
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA