NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
Device Facts
| Record ID | DEN070001 |
|---|---|
| Device Name | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET |
| Applicant | Centers for Disease Control and Prevention |
| Product Code | PBK · Microbiology |
| Decision Date | Sep 21, 2018 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 866.3315 |
| Device Class | Class 2 |
Regulatory Classification
Identification
In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
