510(k) ClearedCE-IVD
Identification of organisms and resistance genes from positive blood cultures
Technical Specifications
PlatformBIOFIRE FILMARRAY
MultiplexYes
Target Count43
Sensitivity≥95%
Specificity≥97%
Turnaround Time1 hr
Storage Temperature2–8°C
Shelf Life18 months
Pathogen Targets (7)
Sample Types
Blood (whole)
Detection Methods
Multiplex PCR