Device Recall Human Alpha1Antitrypsin Kit

  • 모델명 / 제조번호(시리얼번호)
    Lot #400900, Exp. 12/31/2017, UDI #05051700016421
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.
  • 제품 설명
    Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. || Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. 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