510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200066Unknown

BioFire Joint Infection (JI) Panel

BioFire Diagnostics, LLC, Salt Lake City UT / Direct, Unknown
FDA source (opens on fda.gov)

DEN200066 is the FDA 510(k) clearance record for BioFire Joint Infection (JI) Panel, a class II device, cleared for Biofire Diagnostics, LLC on under FDA product code QSN (Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System). FDA's definition for product code QSN reads: "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". FDA records list 35 510(k) clearances for Biofire Diagnostics, LLC, from to . As of , FDA records show no recalls naming DEN200066.

Clearance record

Decision date
Received
(549 days to decision)
Product code
QSN Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Regulation
21 CFR 866.3988
Device class
Class II
Review panel
Microbiology
Applicant
Biofire Diagnostics, LLC 515 Colorow Dr., Salt Lake City UT
Third party review
No

Clearances, product code QSN

Trailing 12 months

FDA records hold no clearances under product code QSN in the trailing twelve months.

FDA records show no clearances under product code QSN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QSN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260