PMA
P190001: therascreen PIK3CA RGQ PCR Kit
FDA PMA · Somatic gene mutation detection system · QIAGEN GmbH
Key facts
| PMA number | P190001 |
|---|---|
| Trade name | therascreen PIK3CA RGQ PCR Kit |
| Generic name | Somatic gene mutation detection system |
| Applicant | QIAGEN GmbH |
| Owner/operator | QIAGEN Sciences LLC |
| Product code | OWD |
| Approval date | May 24, 2019 |
| Docket number | 19M-2560 |
| Notice date | May 28, 2019 |
| Establishment registration | 1122376 |
| FEI number | 3003572099 |
At a glance
- 1–9 Supplements
- Oct 22, 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- No Withdrawn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: