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.
1
Total
0
Cleared
549d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System Devices (Product Code QSN)
1 devices
About Product Code QSN - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QSN since 2022, with 0 receiving FDA clearance (average review time: 549 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
QSN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →