Device Recall Optilite Analyser

  • 모델명 / 제조번호(시리얼번호)
    864000290243  864000290832 864000290244  864000290833 864000290330  864000290834 864000290447  864000290836 864000290448  864000290837 864000290449  864000290838 864000290452  864000290844 864000290826  864000290845 864000290827  864000290846 864000290828  864000290847 864000290831  864000290850
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal.
  • 제품 설명
    Optilite Analyser, Product Code: IE700 || Product Usage: || The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
  • Manufacturer
  • 1 Event

제조사

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