Devices

Device Recall Stago IVD, Liquid AntiXa

  • Modelo / Serial
    510(k) #K111822, Lot #112366, Part # REF 00311US
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed USA (nationwide) and the country of Canada.
  • Descripción del producto
    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. || The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
  • Manufacturer
    Diagnostica Stago, Inc.
  • 1 Event

Fabricante

Diagnostica Stago, Inc.
  • Dirección del fabricante
    Diagnostica Stago, Inc., 5 Century Dr, Parsippany NJ 07054-4607
  • Source
    USFDA