QBH

Lower Respiratory Microbial Nucleic Acid Detection System

Product code

QBH

Device name

Lower Respiratory Microbial Nucleic Acid Detection System

Device class

Class 2

21 CFR

21 CFR 866.3985

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.

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