FDA device listing
4Kscore Test
FDA device listing 1361400951 · OPKO Health, Inc.
Key facts
| Proprietary names | 4Kscore Test |
|---|---|
| Owner/operator | OPKO Health, Inc. |
| Owner/operator number | 10059750 |
| Premarket submissions | P190022 |
| Product codes | QRF |
| Device names | QRF - Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.QRF |
| Review panels | Immunology |
| Registered establishments | BioReference Health, LLC |
| Establishment registrations | 3003652672 |
| FEI numbers | 3003652672 |
| Establishment operations | Complaint File Establishment, 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