# Variola Virus Nucleic Acid-Based Detection Assay
> **Product code: PRA** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3316
## Classification
- **FDA Product Code:** PRA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3316
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PRA)
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