Products/BioFire® FilmArray® Meningitis/Encephalitis (ME) Panel
Multiplex

BioFire® FilmArray® Meningitis/Encephalitis (ME) Panel

BioFire Diagnostics, LLC
510(k) ClearedCE-IVD

Qualitative detection and identification of 14 bacteria, viruses, and yeast causing meningitis and encephalitis from CSF

Technical Specifications

PlatformFilmArray
MultiplexYes
Target Count14
Sensitivity97
Specificity99.6
Turnaround Time1 hr
Storage Temperature2–25°C
Shelf Life12 months

Pathogen Targets (5)

Streptococcus pneumoniae· bacteriaNeisseria meningitidis· bacteriaCryptococcus neoformans/gattii· fungusListeria monocytogenes· bacteriaHerpes Simplex Virus 1/2· virus

Sample Types

CSF

Detection Methods

PCR

Regulatory Status

FDA510(k) Cleared

K151234

510k

10/7/2015

Class: Class II

Source
EMA / CE-IVDCE-IVD

CE 0459

CE-IVD

3/15/2016

Class: Class C

Source

Pricing

USD $150–$200

Per per test

Source: procurement · Confidence: 75%

Source

Pricing is estimated. Contact manufacturer for current pricing.