Products/BioFire® FilmArray® Gastrointestinal (GI) Panel
Multiplex

BioFire® FilmArray® Gastrointestinal (GI) Panel

BioFire Diagnostics, LLC
510(k) ClearedCE-IVD

Qualitative detection and identification of 22 gastrointestinal pathogens including bacteria, viruses, and parasites

Technical Specifications

PlatformFilmArray
MultiplexYes
Target Count22
Sensitivity97.3
Specificity99.5
Turnaround Time1 hr
Storage Temperature2–25°C
Shelf Life12 months

Pathogen Targets (7)

Clostridioides difficile· bacteriaNorovirus GI/GII· virusCryptosporidium· parasiteCampylobacter species· bacteriaSalmonella species· bacteriaShigella/EIEC· bacteriaGiardia lamblia· parasite

Sample Types

Stool

Detection Methods

PCR

Regulatory Status

FDA510(k) Cleared

K140789

510k

10/16/2014

Class: Class II

Source
EMA / CE-IVDCE-IVD

CE 0459

CE-IVD

6/1/2015

Class: Class C

Source

Pricing

USD $150–$200

Per per test

Source: procurement · Confidence: 75%

Source

Pricing is estimated. Contact manufacturer for current pricing.