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

  • 모델명 / 제조번호(시리얼번호)
    Lot #416595, Exp. 31/03/2018; UDI #05051700018319
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution was made to CA. There was no foreign/military/government distribution.
  • 제품 설명
    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

제조사

  • 제조사 주소
    The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
  • 제조사 모회사 (2017)
  • Source
    USFDA