BioFire Diagnostics FilmArray® Pneumonia Panel & Pneumonia Panel Plus - HSA Registration DE0504227
Access comprehensive regulatory information for BioFire Diagnostics FilmArray® Pneumonia Panel & Pneumonia Panel Plus in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0504227 and owned by BioFire Diagnostics, LLC. The device was registered on March 13, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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.