QLT

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Product code

QLT

Device name

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Device class

Class N

Medical specialty

Unknown

Marketing pathway

EUA - Emergency Use Authorization

FDA classification definition

Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.

Definition text from the FDA device classification database (U.S. federal government work, public domain).