PMA
P120014: BIOMERIEUX THXID BRAF ASSAY KIT
FDA PMA · Somatic gene mutation detection system · bioMerieux, Inc.
Key facts
| PMA number | P120014 |
|---|---|
| Trade name | BIOMERIEUX THXID BRAF ASSAY KIT |
| Generic name | Somatic gene mutation detection system |
| Applicant | bioMerieux, Inc. |
| Owner/operator | BIOMERIEUX SA |
| Product code | OWD |
| Approval date | May 29, 2013 |
| Docket number | 13M-0709 |
| Notice date | Jun 14, 2013 |
| Establishment registration | 3002769706 |
| FEI number | 3002769706 |
At a glance
- 10–99 Supplements
- Dec 20, 2021 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: