Respiratory Panel
FDA product code QDP · Class II (moderate risk) · 21 CFR 866.3985 · Microbiology
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.
2510(k) clearances
0PMA approvals
0recalls