Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

QSN · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3988

Classification

FDA Product Code: QSN
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3988
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown