CELLDYN Sapphire Hematology Analyzer

  • 모델명 / 제조번호(시리얼번호)
    List 08H00-01, 08H00-03, PCB Assembly part number 8960167101
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to 926 retailers throughout the US and to argentina, Australia, Brazil, Canada, Chile, China, Columbia, Germany, Hong King, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.
  • 제품 설명
    CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    All pre production units with Serial numbers S-001 to S-026 and all production units with serial numbers 42003AZ-42007AZ, 42010AZ-42030AZ, 42032AZ-42033AZ, 42037AZ-42059AZ, 42061AZ-42062AZ, 42064AZ-42067AZ, 42072AZ-42074AZ, 42076AZ-42081AZ, 42083AZ-42123AZ, 42125AZ-42852AZ, 42854AZ-42944AZ, 42946AZ-42949AZ, 42951AZ, 42953AZ, 42955AZ-42961AZ, and 42963AZ-42964AZ
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Argentina, Australia, Brazil, Canada, Chile, China WFOTC, Colombia, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela.
  • 제품 설명
    CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 || A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells.
  • Manufacturer