Products/BIOFIRE FILMARRAY Meningitis/Encephalitis Panel
Multiplex

BIOFIRE FILMARRAY Meningitis/Encephalitis Panel

bioMérieux
510(k) ClearedCE-IVD

Detection of pathogens in CSF from patients with suspected meningitis or encephalitis

Technical Specifications

PlatformBIOFIRE FILMARRAY
MultiplexYes
Target Count14
Sensitivity≥90%
Specificity≥97%
Turnaround Time1 hr
Storage Temperature2–8°C
Shelf Life18 months

Pathogen Targets (3)

Streptococcus pneumoniae· bacteriaE. coli· bacteriaNeisseria gonorrhoeae· bacteria

Sample Types

CSF

Detection Methods

Multiplex PCR

Regulatory Status

FDA510(k) Cleared

K152715

510(k)

10/7/2015

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $200–$260

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.