QSN

Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

Product code: QSN
Device name: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Device class: Class 2
21 CFR: 21 CFR 866.3988
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections.

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

Official FDA classification page: QSN

Classification and pathway per current FDA publications. Data from openFDA (CC0).