De Novo
DEN130032: XPERT MTB/RIF ASSAY
FDA De Novo · cepheid · decided Jul 25, 2013
Key facts
| De Novo number | DEN130032 |
|---|---|
| Device name | XPERT MTB/RIF ASSAY |
| Applicant | cepheid |
| Product code | PEU |
| Date received | Jun 11, 2013 |
| Decision date | Jul 25, 2013 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 3004530258 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 1–9 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: