Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3316](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3316) → PRA — Variola Virus Nucleic Acid-Based Detection Assay

# PRA · Variola Virus Nucleic Acid-Based Detection Assay

_Microbiology · 21 CFR 866.3316 · Class 2_

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

## Overview

- **Product Code:** PRA
- **Device Name:** Variola Virus Nucleic Acid-Based Detection Assay
- **Regulation:** [21 CFR 866.3316](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3316)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection.  The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN160016](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PRA/DEN160016.md) | Variola virus Real-Time PCR Assay | Centers For Disease Control and Prevention (CDC) | Feb 6, 2017 | DENG |

## Top Applicants

- Centers For Disease Control and Prevention (CDC) — 1 clearance

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

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