Device Recall Cepheid Xpert Flu A Panel (GXFLUPANEL10)

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 00401, 00502, 00701, 00702 (Expires 2010 07 11 for lot 00401 and 2010 09 05 for the rest).
  • 의료기기 분류등급
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
  • 제품 설명
    Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. || Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.
  • Manufacturer
  • 1 Event

제조사

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