Device Recall BioRad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set

  • 모델명 / 제조번호(시리얼번호)
    Medical device, intended for percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography, intended for professional use only.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, and the United Kingdom
  • 제품 설명
    Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA