DeviceClearance

Product code QSN— Microbiology

BioFire Joint Infection (JI) Panel

Classification name
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Device class
Class 2
Regulation
21 CFR 866.3988
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QSN under 21 CFR 866.3988, via openFDA

Market context for product code QSN

FDA has cleared 1 device under product code QSN, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QSN

Recent clearances under product code QSN

Data sourced from openFDA. This site is unofficial and independent of the FDA.