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

  • Modèle / numéro de série
    Lot #416595, Exp. 31/03/2018; UDI #05051700018319
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution was made to CA. There was no foreign/military/government distribution.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
  • Société-mère du fabricant (2017)
  • Source
    USFDA