De Novo
DEN170041: GeneSTAT.MDx Coccidioides Assay
FDA De Novo · dxna, llc · decided Nov 29, 2017
Key facts
| De Novo number | DEN170041 |
|---|---|
| Device name | GeneSTAT.MDx Coccidioides Assay |
| Applicant | dxna, llc |
| Product code | QAA |
| Date received | Aug 1, 2017 |
| Decision date | Nov 29, 2017 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
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: