BIOFIRE FILMARRAY GI Panel

510(k) ClearedCE-IVD

Detection of gastrointestinal pathogens from stool specimens

Technical Specifications

PlatformBIOFIRE FILMARRAY

MultiplexYes

Target Count22

Sensitivity≥93%

Specificity≥96%

Turnaround Time1 hr

Storage Temperature2–8°C

Shelf Life18 months

Stool/Feces

Multiplex PCR

FDA510(k) Cleared

K143072

510(k)

5/14/2014

EMA / CE-IVDCE-IVD

Class: Class C

USD $170–$220

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.