Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3988](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3988) → QSN — Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

# QSN · Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

_Microbiology · 21 CFR 866.3988 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QSN

## Overview

- **Product Code:** QSN
- **Device Name:** Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
- **Regulation:** [21 CFR 866.3988](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3988)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN200066](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QSN/DEN200066.md) | BioFire Joint Infection (JI) Panel | Biofire Diagnostics, LLC | Apr 29, 2022 | DENG |

## Top Applicants

- Biofire Diagnostics, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QSN](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QSN)

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