QSNClass II
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Microbiology · 21 CFR 866.3988
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.
MDR events9All time
Recalls1All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
9 adverse event reports on file
- BioFire Joint Infection PanelJul 14, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00017
- BioFire Joint Infection PanelJul 14, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00018
- BIOFIRE JOINT INFECTION (JI) PANELMay 28, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00015
- BIOFIRE JOINT INFECTION (JI) PANELMay 28, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00014
- BIOFIRE JOINT INFECTION PANELMay 27, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00013
- BIOFIRE JOINT INFECTION PANELMay 26, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00012
- BIOFIRE JOINT INFECTION PANELApr 1, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00004
- BIOFIRE JOINT INFECTION (JI) PANELApr 1, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00005
- BIOFIRE JOINT INFECTION PANELApr 1, 2026MalfunctionBiofire Diagnostics, Llc3002773840-2026-00006
Event type breakdown
Malfunction9
Most-reported manufacturers
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code