Cepheid

12 devices in the database

  • Model / Serial
    Lot Number : 1402
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089
  • Model / Serial
    Lot numbers: 25718, 25719, 25725, and 25727.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Puerto Rico, and Haiti.
  • Product Description
    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. || Is a qualitative in vitro real-time PCR test.
  • Model / Serial
    batch 1000045409 (lot 06802)
  • Distribution
    USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay
  • Product Description
    Xpert EV Assay, Catalog GXEV-100N-10. || The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis.
  • Model / Serial
    Lot Number: 00501 (Expires 2010 08 08)
  • Product Classification
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
  • Product Description
    Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-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.
  • Model / Serial
    Lot Numbers: 00401, 00502, 00701, 00702 (Expires 2010 07 11 for lot 00401 and 2010 09 05 for the rest).
  • Product Classification
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
  • Product Description
    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.
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