FDA device listing
Nova Stat Profile Critical Care Xpress
FDA device listing 1413773063 · NOVA BIOMEDICAL CORP.
Key facts
| Proprietary names | Nova Stat Profile Critical Care Xpress |
|---|---|
| Owner/operator | NOVA BIOMEDICAL CORP. |
| Owner/operator number | 1219029 |
| Premarket submissions | K022746 |
| Product codes | CDS, CEM, CFA, CGA, CGL, CGZ, CHL, GHS, GKR, JFP, JGS, JIX and 5 more |
| Device names | CDS - Electrode, Ion Specific, Urea Nitrogen, CEM - Electrode, Ion Specific, Potassium, CFA - Electrode, Ion Specific, Magnesium, CGA - Glucose Oxidase, Glucose, CGL - Electrode, Ion Based, Enzymatic, Creatinine, CGZ - Electrode, Ion-Specific, Chloride, CHL - Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, GHS - Assay, Carboxyhemoglobin, GKR - System, Hemoglobin, Automated, JFP - Electrode, Ion Specific, Calcium, JGS - Electrode, Ion Specific, Sodium, JIX - Calibrator, Multi-Analyte Mixture and 5 more |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1120, 862.1145, 862.1150, 862.1170, 862.1225, 862.1345, 862.1450, 862.1495, 862.1600, 862.1660, 862.1665, 862.1770 and 5 more |
| Review panels | Clinical Chemistry, Clinical Toxicology, Hematology |
| Registered establishments | NOVA BIOMEDICAL CORPORATION |
| Establishment registrations | 1219029 |
| FEI numbers | 1219029 |
| Establishment operations | Manufacturer |
| 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