Device Recall Great Basin Staph lD/R Blood Culture Panel

  • Modelo / Serial
    Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    Great Basin Staph lD/R Blood Culture Panel || The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Great Basin Scientific, Inc., 2441 S 3850 W, Salt Lake City UT 84120-7209
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA