FDA device listing
Q.STEPS Cholesterol Meter System,Q.Steps G/C Monitoring system(Glucose/TC); Q.Steps Glucose Meter system
FDA device listing 1554063380 · BiometerPlus USA, Inc.
Key facts
| Proprietary names | Q.STEPS Cholesterol Meter System,Q.Steps G/C Monitoring system(Glucose/TC); Q.Steps Glucose Meter system |
|---|---|
| Owner/operator | BiometerPlus USA, Inc. |
| Owner/operator number | 10046647 |
| Premarket submissions | K033627 |
| 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 | BiometerPlus USA, Inc. |
| Establishment registrations | 3010830834 |
| FEI numbers | 3004525092 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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