VITEK MS is an AI-enabled medical device from BIOMERIEUX, INC., listed by FDA (De Novo, DEN130013) with a decision date of 2013-08-21. Review panel: Microbiology.
| FDA submission number | DEN130013 |
|---|---|
| Pathway | De Novo |
| Company | BIOMERIEUX, INC. |
| Review panel (specialty) | Microbiology |
| FDA decision date | 2013-08-21 |
| Decision | Unknown |
| Product code | PEX |
| Classification | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Device class | 2 |
| Regulation number | 866.3361 |
| Review time (calendar days) | 231 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.