De Novo
BR190330: Sentosa SQ HIV Genotyping Assay
FDA De Novo · Vela Diagnostics USA Inc · decided Nov 5, 2019
Key facts
| De Novo number | BR190330 |
|---|---|
| Device name | Sentosa SQ HIV Genotyping Assay |
| Applicant | Vela Diagnostics USA Inc |
| Product code | QIC |
| Date received | Mar 19, 2019 |
| Decision date | Nov 5, 2019 |
| Decision | Granted - Direct De Novo |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 3009694456 |
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: