Products/BioFire® Respiratory 2.1 (RP2.1) Panel
Multiplex

BioFire® Respiratory 2.1 (RP2.1) Panel

BioFire Diagnostics, LLC
510(k) ClearedCE-IVD

Qualitative detection and identification of multiple respiratory pathogens from nasopharyngeal swab specimens

Technical Specifications

PlatformFilmArray
MultiplexYes
Target Count22
Sensitivity96.4
Specificity99.5
Turnaround Time45 min
Storage Temperature2–25°C
Shelf Life12 months

Pathogen Targets (11)

SARS-CoV-2· virusInfluenza A· virusInfluenza B· virusAdenovirus· virusRhinovirus/Enterovirus· virusMycoplasma pneumoniae· bacteriaBordetella pertussis· bacteriaRespiratory Syncytial Virus A/B· virusHuman Metapneumovirus· virusParainfluenza Virus 1/2/3/4· virusChlamydia pneumoniae· bacteria

Sample Types

Nasopharyngeal swab

Detection Methods

PCR

Regulatory Status

FDA510(k) Cleared

K201234

510k

9/4/2020

Class: Class II

Source
EMA / CE-IVDCE-IVD

CE 0459

CE-IVD

5/26/2021

Class: Class C

Source

Pricing

USD $150–$200

Per per test

Source: procurement · Confidence: 75%

Source

Pricing is estimated. Contact manufacturer for current pricing.