De Novo
DEN220042: Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
FDA De Novo · terragene sa · decided Jul 12, 2024
Key facts
| De Novo number | DEN220042 |
|---|---|
| Device name | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) |
| Applicant | terragene sa |
| Product code | QVB |
| Date received | Jul 1, 2022 |
| Decision date | Jul 12, 2024 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
| FEI number | 3013145340 |
At a glance
- 1–9 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: