Device Recall Beta2Microglobulin Urine Kit

  • Modèle / numéro de série
    Lot 407460, UDI 05051700017688
  • 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
    Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. || The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. 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