Products/BIOFIRE FILMARRAY Respiratory Panel 2.1
Multiplex

BIOFIRE FILMARRAY Respiratory Panel 2.1

bioMérieux
510(k) ClearedCE-IVD

Detection and identification of multiple respiratory pathogens from nasopharyngeal swabs

Technical Specifications

PlatformBIOFIRE FILMARRAY
MultiplexYes
Target Count22
Sensitivity≥95%
Specificity≥97%
Turnaround Time45 min
Storage Temperature2–8°C
Shelf Life18 months

Pathogen Targets (10)

SARS-CoV-2· virusInfluenza A· virusInfluenza B· virusRSV· virusAdenovirus· virusMetapneumovirus· virusParainfluenza 1-4· virusRhinovirus/Enterovirus· virusMycoplasma pneumoniae· bacteriaBordetella pertussis· bacteria

Sample Types

Nasopharyngeal swab

Detection Methods

Multiplex PCR

Regulatory Status

FDA510(k) Cleared

K213178

510(k)

10/15/2021

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $150–$200

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.