QDP

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Respiratory Panel

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3985

Medical specialty

Microbiology

FDA definition

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.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free