PMA
P180043: therascreen FGFR RGQ RT-PCR Kit
FDA PMA · Somatic gene mutation detection system · QIAGEN GmbH
Key facts
| PMA number | P180043 |
|---|---|
| Trade name | therascreen FGFR RGQ RT-PCR Kit |
| Generic name | Somatic gene mutation detection system |
| Applicant | QIAGEN GmbH |
| Owner/operator | QIAGEN Sciences LLC |
| Product code | OWD |
| Approval date | Apr 12, 2019 |
| Docket number | 19M-1979 |
| Notice date | Apr 26, 2019 |
| Establishment registration | 1122376 |
| FEI number | 3003572099 |
At a glance
- 10–99 Supplements
- May 6, 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- No Withdrawn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: