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

Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

21 CFR 866.3988 / Microbiology
FDA source (opens on fda.gov)

QSN is the FDA product code for Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System, a class II device type, regulated under 21 CFR 866.3988. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
QSN
Device name
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
FDA 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.
Regulation
21 CFR 866.3988
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code QSN

By decision year
1 clearance under product code QSN with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QSN by decision year
YearClearances
20221

Applicants with the most clearances

Product code QSN
Applicants holding the most 510(k) clearances under product code QSN
ApplicantClearances
BioFire Diagnostics, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code