Singapore HSA registration DE0504227
BioFire Diagnostics FilmArray® Pneumonia Panel & Pneumonia Panel Plus
Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0504227
- Registration Date
- March 13, 2020
- Change Notification Approval Date
- April 01, 2024
- Retention Due Date
- March 12, 2026
Product description
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.
Product Owner
- Short Name
- BioFire Diagnostics, LLC
- Address
- 515 Colorow Dr., Salt Lake city, Utah, 84108, UNITED STATES
Registrant
- Address
- 11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667
Importer
- Address
- 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model information
- Model Name(s)
- FilmArray® Pneumonia Panel Plus, 6 Pack FilmArray® Pneumonia Panel Plus, 30 Pack FilmArray® Pneumonia Panel, 30 Pack FilmArray® Pneumonia Panel, 6 Pack
- Model Identifier(s)
- RFIT-ASY-0142 RFIT-ASY-0143 RFIT-ASY-0144 RFIT-ASY-0145
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD