FDA device listing
INFINITI Warfarin Assay
FDA device listing 1767741520 · Prescient Medicine Holdings Inc DBA SOLVD Health
Key facts
| Proprietary names | INFINITI Warfarin Assay |
|---|---|
| Owner/operator | Prescient Medicine Holdings Inc DBA SOLVD Health |
| Owner/operator number | 10061771 |
| Premarket submissions | K073014 |
| Product codes | NSU, ODV, ODW |
| Device names | NSU - Instrumentation For Clinical Multiplex Test Systems, ODV - Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System, ODW - Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570, 862.3360, 864.7750 |
| Review panels | Clinical Chemistry, Clinical Toxicology, Hematology |
| Registered establishments | AUTOGENOMICS, INCORPORATED |
| Establishment registrations | 3005406097 |
| FEI numbers | 3005406097 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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