Device Recall Hemochron Signature Elite Whole Blood Microcoagulation System

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618.
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore.
  • 제품 설명
    Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. || The system is intended to be used only with test cuvettes that are available from ITC.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • 제조사 모회사 (2017)
  • Source
    USFDA