De Novo
DEN180047: Aptima Mycoplasma genitalium Assay
FDA De Novo · hologic, inc. · decided Jan 23, 2019
Key facts
| De Novo number | DEN180047 |
|---|---|
| Device name | Aptima Mycoplasma genitalium Assay |
| Applicant | hologic, inc. |
| Product code | QEP |
| Date received | Aug 31, 2018 |
| Decision date | Jan 23, 2019 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 2024800 |
At a glance
- 1–9 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: