Products/BioFire® FilmArray® Pneumonia (PN) Panel
Multiplex

BioFire® FilmArray® Pneumonia (PN) Panel

BioFire Diagnostics, LLC
510(k) ClearedCE-IVD

Qualitative and semi-quantitative detection of 33 bacteria, viruses, and resistance markers from lower respiratory specimens

Technical Specifications

PlatformFilmArray
MultiplexYes
Target Count33
Sensitivity96.2
Specificity98.9
Turnaround Time1 hr
Storage Temperature2–25°C
Shelf Life12 months

Pathogen Targets (5)

Mycoplasma pneumoniae· bacteriaStreptococcus pneumoniae· bacteriaKlebsiella pneumoniae· bacteriaPseudomonas aeruginosa· bacteriaStaphylococcus aureus (MRSA)· bacteria

Sample Types

Bronchoalveolar lavage

Detection Methods

PCR

Regulatory Status

FDA510(k) Cleared

K200678

510k

1/22/2020

Class: Class II

Source
EMA / CE-IVDCE-IVD

CE 0459

CE-IVD

9/1/2020

Class: Class C

Source

Pricing

USD $150–$200

Per per test

Source: procurement · Confidence: 75%

Source

Pricing is estimated. Contact manufacturer for current pricing.