Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
BIOMERIEUX SINGAPORE PTE. LTD.
Class C IVD
BioFire Diagnostics, LLC
Microbiology
The BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) & Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) are multiplexed nucleic acid test intended for use with BIOFIRE® FILMARRAY® 2.0 (BIOFIRE 2.0) or BIOFIRE® FILMARRAY® TORCH (BIOFIRE TORCH) systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection. The detection and identification of MERS-CoV is only available on the BIOFIRE® FILMARRAY® Pneumonia Panel plus. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Models: FilmArray® Pneumonia Panel, 30 Pack - RFIT-ASY-0144, FilmArray® Pneumonia Panel, 6 Pack - RFIT-ASY-0145, FilmArray® Pneumonia Panel Plus, 6 Pack - RFIT-ASY-0142, FilmArray® Pneumonia Panel Plus, 30 Pack - RFIT-ASY-0143
2020-03-13