Variola virus Real-Time PCR Assay
Device Facts
| Record ID | DEN160016 |
|---|---|
| Device Name | Variola virus Real-Time PCR Assay |
| Applicant | Centers For Disease Control and Prevention (CDC) |
| Product Code | PRA · Microbiology |
| Decision Date | Feb 6, 2017 |
| Decision | DENG |
| Submission Type | Direct |
| Regulation | 21 CFR 866.3316 |
| Device Class | Class 2 |
Regulatory Classification
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.
