FDA Product Code QDP: Respiratory Panel
The Panel Is A Multiplexed Nucleic Acid Test Intended For Use With 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.
Leading manufacturers include Biofire Diagnostics, LLC.
List of Respiratory Panel devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Respiratory Panel devices (product code QDP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →