FDA Product Code QSN: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
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.
Leading manufacturers include Biofire Diagnostics, LLC.
List of Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System devices (product code QSN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →