PMA
P250005: Idylla CDx MSI Test
FDA PMA · Nucleic Acid Based Assay, Microsatellite Instability · Biocartis Us, Inc.
Key facts
| PMA number | P250005 |
|---|---|
| Trade name | Idylla CDx MSI Test |
| Generic name | Nucleic Acid Based Assay, Microsatellite Instability |
| Applicant | Biocartis Us, Inc. |
| Owner/operator | Biocartis US, Inc. |
| Product code | SFL |
| Approval date | Aug 15, 2025 |
| Establishment registration | 3031824615 |
| FEI number | 3031824615 |
At a glance
- None Supplements
- Aug 15, 2025 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- No Withdrawn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: