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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthopedic infection microbial multiplex nucleic acid detection system
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.
Product CodeQSN
Regulation Number 866.3988
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DIAGNOSTICS, LLC
  GRANTED 1

MDR Year MDR Reports MDR Events
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II May-06-2026
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