FDA device listing
Stat Profile Prime Plus
FDA device listing 1581561107 · NOVA BIOMEDICAL CORP.
Key facts
| Proprietary names | Stat Profile Prime Plus |
|---|---|
| Owner/operator | NOVA BIOMEDICAL CORP. |
| Owner/operator number | 1219029 |
| Premarket submissions | K180186 |
| Product codes | GGZ, GHS, GKK, GKR, JPI |
| Device names | GGZ - Oxyhemoglobin, GHS - Assay, Carboxyhemoglobin, GKK - Cyanomethemoglobin, GKR - System, Hemoglobin, Automated, JPI - Device, Hematocrit Measuring |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5620, 864.6400, 864.7425, 864.7500 |
| Review panels | Hematology |
| Registered establishments | Nova Biomedical Corporation, NOVA BIOMEDICAL CORPORATION |
| Establishment registrations | 1219029, 3023162659 |
| FEI numbers | 1219029, 3023162659 |
| Establishment operations | Manufacturer, Remanufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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