PMA
P220006: VENTANA FOLR1 (FOLR-2.1) RxDx Assay
FDA PMA · Immunohistochemistry Assay, Antibody, FOLR1 · Ventana Medical Systems, Inc.
Key facts
| PMA number | P220006 |
|---|---|
| Trade name | VENTANA FOLR1 (FOLR-2.1) RxDx Assay |
| Generic name | Immunohistochemistry Assay, Antibody, FOLR1 |
| Applicant | Ventana Medical Systems, Inc. |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | QUL |
| Approval date | Nov 14, 2022 |
| Docket number | 22M-2869 |
| Notice date | Nov 18, 2022 |
| Establishment registration | 2028492 |
| FEI number | 1000125183 |
At a glance
- 1–9 Supplements
- Jun 20, 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- No Withdrawn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: