Devices

Device Recall SmartCycler

  • 모델명 / 제조번호(시리얼번호)
    All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
  • 제품 설명
    SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
  • Manufacturer
    Cepheid
  • 1 Event

제조사

Cepheid
  • 제조사 주소
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA