Device Recall PROTrac II Tacrolimus ELISA kit

  • 모델명 / 제조번호(시리얼번호)
    131716, 131716A, 131716B, 131716C, 131716D, 131716E,  131717.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
  • 제품 설명
    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. || Product Usage: || The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • 제조사 모회사 (2017)
  • Source
    USFDA