Device Recall Troponin I STAT Immunoassay

  • 모델명 / 제조번호(시리얼번호)
    Elecsys Troponin I STAT Immunoassay, 05094798160- lot 163177
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. Argentina, Kenya, Austria, South Korea, Belgium, Kuwait, Bahrain, Morocco, Brazil, Mexico, Switzerland, Nigeria, Chile, New Zealand, Columbia, Philippines, Germany, Pakistan, Algeria, Poland, Egypt, Qatar, Spain, Tunisia, France, Turkey, United Kingdom, Taiwan, India, Ukraine, Iran, Venezuela, Italy, South Africa, Jordan, and Armenia.
  • 제품 설명
    Elecsys Troponin I STAT Immunoassay || For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
  • Source
    USFDA