FDA device listing
Stat Profile Prime ES Comp Plus Analyzer System
FDA device listing 1771284210 · NOVA BIOMEDICAL CORP.
Key facts
| Proprietary names | Stat Profile Prime ES Comp Plus Analyzer System |
|---|---|
| Owner/operator | NOVA BIOMEDICAL CORP. |
| Owner/operator number | 1219029 |
| Premarket submissions | K191365 |
| Product codes | CEM, CGZ, JGS, JJE |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGZ - Electrode, Ion-Specific, Chloride, JGS - Electrode, Ion Specific, Sodium, JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1170, 862.1600, 862.1665, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | Nova Biomedical Corporation, NOVA BIOMEDICAL CORPORATION |
| Establishment registrations | 1219029, 3023162659 |
| FEI numbers | 1219029, 3023162659 |
| Establishment operations | Complaint File Establishment, 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