De Novo
DEN180040: Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
FDA De Novo · meridian bioscience, inc. · decided Nov 30, 2018
Key facts
| De Novo number | DEN180040 |
|---|---|
| Device name | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit |
| Applicant | meridian bioscience, inc. |
| Product code | QDZ |
| Date received | Jul 30, 2018 |
| Decision date | Nov 30, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 1524213 |
At a glance
- 1–9 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: