PMA
P210001: VENTANA MMR RxDx Panel
FDA PMA · Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Key facts
| PMA number | P210001 |
|---|---|
| Trade name | VENTANA MMR RxDx Panel |
| Generic name | Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay |
| Applicant | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | QNH |
| Approval date | Aug 17, 2021 |
| Docket number | 21M-0915 |
| Notice date | Aug 25, 2021 |
| Establishment registration | 2028492 |
| FEI number | 1000125183 |
At a glance
- 10–99 Supplements
- Oct 8, 2026 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- No Withdrawn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: