PRA — Variola Virus Nucleic Acid-Based Detection Assay Class II
FDA product code PRA covers "Variola Virus Nucleic Acid-Based Detection Assay", a Class II medical device regulated under 21 CFR 866.3316. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PRA
- Device Class
- Class II
- Regulation Number
- 866.3316
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN160016 | centers for disease control and prevention (cdc) | Variola virus Real-Time PCR Assay | February 6, 2017 |