Device Recall HemoCue Albumin 201 Analyzer

  • 모델명 / 제조번호(시리얼번호)
    See serial numbers of affected devices in attachment profided by firm.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
  • 제품 설명
    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. || The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    HemoCue AB, Kuvettgaten 1, Angelholm Sweden
  • 제조사 모회사 (2017)
  • Source
    USFDA