Device Recall Beta2Microglobulin Urine Kit

  • 모델명 / 제조번호(시리얼번호)
    Lot 407460, UDI 05051700017688
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution was made to CA. There was no foreign/military/government distribution.
  • 제품 설명
    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

제조사

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