Cepheid Xpert MRSA/SA Blood Culture

  • Modèle / numéro de série
    Product codes GXMRSA/SA-BC-10 (lot numbers 00601, 00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101, 01102, 01301, 01302) and GXMRSA/SA-BC-CE-10 (lot numbers 01001, 01101, 01301)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Europe, Taiwan, and Australia.
  • Description du dispositif
    Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. || Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • Société-mère du fabricant (2017)
  • Source
    USFDA