← Product Code [PRA](/submissions/MI/subpart-d%E2%80%94serological-reagents/PRA) · DEN160016

# Variola virus Real-Time PCR Assay (DEN160016)

_Centers For Disease Control and Prevention (CDC) · PRA · Feb 6, 2017 · Microbiology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PRA/DEN160016

## Device Facts

- **Applicant:** Centers For Disease Control and Prevention (CDC)
- **Product Code:** [PRA](/submissions/MI/subpart-d%E2%80%94serological-reagents/PRA.md)
- **Decision Date:** Feb 6, 2017
- **Decision:** DENG
- **Submission Type:** Direct
- **Regulation:** 21 CFR 866.3316
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PRA/DEN160016](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PRA/DEN160016)

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