Device type
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Product code QSN · Class II · 21 CFR 866.3988 · Microbiology
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.
Recent 510(k)s
No 510(k) clearances in the archive for QSN.
Recent recalls
Oct 21, 2026
Z-0150-2027
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135…
BioFire Diagnostics, LLC
- QSN
- Class II
- Ongoing