FDA device listing
digene® HC2 High-Risk HPV DNA Test,digene® HC2 HPV DNA Test,DML 3000
FDA device listing 2047587540 · QIAGEN Sciences LLC
Key facts
| Proprietary names | digene® HC2 High-Risk HPV DNA Test,digene® HC2 HPV DNA Test,DML 3000 |
|---|---|
| Owner/operator | QIAGEN Sciences LLC |
| Owner/operator number | 9002668 |
| Premarket submissions | P890064 |
| Product codes | MAQ |
| Device names | MAQ - Kit, Dna Detection, Human Papillomavirus |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MAQ |
| Review panels | Microbiology |
| Registered establishments | QIAGEN |
| Establishment registrations | 1122376 |
| FEI numbers | 3003572099 |
| Establishment operations | Manufacturer, Specification Developer |
| 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