Device Recall Rheumatoid Factor (RF) Kit for use on SPAPLUS

  • Modelo / Serial
    Lot #416595, Exp. 31/03/2018; UDI #05051700018319
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution was made to CA. There was no foreign/military/government distribution.
  • Descripción del producto
    Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A || Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA