FDA device listing
Fortel Microalbumin Screening,Microalbumin
FDA device listing 1686535906 · Biomerica, Inc.
Key facts
| Proprietary names | Fortel Microalbumin Screening,Microalbumin |
|---|---|
| Owner/operator | Biomerica, Inc. |
| Owner/operator number | 2016793 |
| Product codes | JIQ |
| Device names | JIQ - Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1645 |
| Review panels | Clinical Chemistry |
| Registered establishments | BIOMERICA DE MEXICO, S.A. DE C.V. |
| Establishment registrations | 3004569406 |
| FEI numbers | 3004569406 |
| Establishment operations | Manufacturer |
| 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