FDA device listing
Focus,Focus Pro,True Focus Pro
FDA device listing 1139998119 · NOVA BIOMEDICAL CORP.
Key facts
| Proprietary names | Focus,Focus Pro,True Focus Pro |
|---|---|
| Owner/operator | NOVA BIOMEDICAL CORP. |
| Owner/operator number | 1219029 |
| Premarket submissions | K131013 |
| Product codes | JJX, LFR, NBW |
| Device names | JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), LFR - Glucose Dehydrogenase, Glucose, NBW - System, Test, Blood Glucose, Over The Counter |
| 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, U.S. Manufacturer of Export Only Devices |
| 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