Devices

Device Recall ZYMUTEST HIA MonoStrip IgG ELISA

  • Modelo / Serial
    Lot numbers: F1701084P2 and F1701084P3
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    OH, MD, NC, NY, NH, Canada, Sweden
  • Descripción del producto
    ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
  • Manufacturer
    Hyphen BioMed
  • 1 Event

Fabricante

Hyphen BioMed
  • Dirección del fabricante
    Hyphen BioMed, 155 rue d Eragny, Neuville Sur Oise France
  • Empresa matriz del fabricante (2017)
    Hyphen Biomed
  • Source
    USFDA