FDA device listing
therascreen PDGFRA RGQ PCR Kit
FDA device listing 1442151423 · QIAGEN, GmbH
Key facts
| Proprietary names | therascreen PDGFRA RGQ PCR Kit |
|---|---|
| Owner/operator | QIAGEN, GmbH |
| Owner/operator number | 9065957 |
| Premarket submissions | P210002 |
| Product codes | OWD |
| Device names | OWD - Somatic Gene Mutation Detection System |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OWD |
| Review panels | Pathology |
| Registered establishments | QIAGEN, GMBH |
| Establishment registrations | 3004013603 |
| FEI numbers | 3004013603 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database