Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart D — Serological Reagents](/submissions/IM/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.4000](/submissions/IM/subpart-d%E2%80%94serological-reagents/866.4000) → QVR — Multiplex Nucleic Acid Detection System For Biothreat Agents

# QVR · Multiplex Nucleic Acid Detection System For Biothreat Agents

_Immunology · 21 CFR 866.4000 · Class 2_

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

## Overview

- **Product Code:** QVR
- **Device Name:** Multiplex Nucleic Acid Detection System For Biothreat Agents
- **Regulation:** [21 CFR 866.4000](/submissions/IM/subpart-d%E2%80%94serological-reagents/866.4000)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K231336](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/QVR/K231336.md) | T2 Biothreat Panel | T2biosystems, Inc. | Sep 15, 2023 | SESE |
| [K213362](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94serological-reagents/QVR/K213362.md) | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | Biofire Defense, LLC | Mar 22, 2023 | SESE |

## Top Applicants

- T2biosystems, Inc. — 1 clearance
- Biofire Defense, LLC — 1 clearance

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

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