De Novo
DEN200015: cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
FDA De Novo · roche molecular systems, inc. · decided Jul 30, 2020
Key facts
| De Novo number | DEN200015 |
|---|---|
| Device name | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit |
| Applicant | roche molecular systems, inc. |
| Product code | QLX |
| Date received | Mar 2, 2020 |
| Decision date | Jul 30, 2020 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Microbiology |
| FEI number | 1000250259 |
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: