De Novo
DEN070013: ID-TAG RESPIRATORY VIRAL PANEL
FDA De Novo · luminex molecular diagnostics, inc. · decided Jan 3, 2008
Key facts
| De Novo number | DEN070013 |
|---|---|
| Device name | ID-TAG RESPIRATORY VIRAL PANEL |
| Applicant | luminex molecular diagnostics, inc. |
| Product code | OCC |
| Date received | Dec 4, 2007 |
| Decision date | Jan 3, 2008 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 3002777243 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 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: