FDA device listing
51184 Menarini Glucofix Mio Premium,51185 Menarini Glucofix Mio Premium,Nipro StatStrip XP3,Nova Pro B-Ketone Test…
FDA device listing 1089609831 · NOVA BIOMEDICAL CORP.
Key facts
| Proprietary names | 51184 Menarini Glucofix Mio Premium,51185 Menarini Glucofix Mio Premium,Nipro StatStrip XP3,Nova Pro B-Ketone Test Strips,Nova Pro Glucose and B-Ketone Controls and Linearity Solutions,Nova Pro Glucose and B-Ketone Meter,Nova Pro Glucose Test Strips,Nova StatStrip Glucose and B-Ketone Controls and Linearity Solutions,Nova StatStrip Glucose and B-Ketone Meter,Nova StatStrip Xpress Glucose and… |
|---|---|
| Owner/operator | NOVA BIOMEDICAL CORP. |
| Owner/operator number | 1219029 |
| Product codes | CGA |
| Device names | CGA - Glucose Oxidase, Glucose |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1345 |
| 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 | Contract Manufacturer, Manufacturer, U.S. Manufacturer of Export Only Devices |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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