De Novo
DEN070001: NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
FDA De Novo · centers for disease control and prevention · decided Sep 21, 2018
Key facts
| De Novo number | DEN070001 |
|---|---|
| Device name | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET |
| Applicant | centers for disease control and prevention |
| Product code | PBK |
| Date received | Jan 16, 2007 |
| Decision date | Sep 21, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 1050190 |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: