FDA device listing
Nova StatStrip
FDA device listing 2025041211 · NOVA BIOMEDICAL CORP.
Key facts
| Proprietary names | Nova StatStrip |
|---|---|
| Owner/operator | NOVA BIOMEDICAL CORP. |
| Owner/operator number | 1219029 |
| Premarket submissions | K063821 |
| Product codes | CGA, JJX |
| Device names | CGA - Glucose Oxidase, Glucose, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1345, 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | Nova Biomedical Corporation, NOVA BIOMEDICAL CORPORATION, NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS |
| Establishment registrations | 1219029, 3004193489, 3011979858 |
| FEI numbers | 1219029, 3004193489, 3011979858 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer, Remanufacturer |
| 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