Device Recall Roche/Hitachi MODULAR E170 Analytics System

  • 모델명 / 제조번호(시리얼번호)
    Not applicable
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Roche/Hitachi MODULAR Analytics Combination Systems || Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer || Product Usage: || The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
  • Manufacturer
  • 1 Event

제조사

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