FDA device listing
cTnI AccuBind® ELISA Test System (Ref 3825-300A and 3825-300B),cTnI AccuLite® CLIA Test System (Ref 3875-300A and…
FDA device listing 1437856817 · MONOBIND, INC.
Key facts
| Proprietary names | cTnI AccuBind® ELISA Test System (Ref 3825-300A and 3825-300B),cTnI AccuLite® CLIA Test System (Ref 3875-300A and 3875-300B) |
|---|---|
| Owner/operator | MONOBIND, INC. |
| Owner/operator number | 2020726 |
| Product codes | MMI |
| Device names | MMI - Immunoassay Method, Troponin Subunit |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1215 |
| Review panels | Clinical Chemistry |
| Registered establishments | MONOBIND, INC. |
| Establishment registrations | 2020726 |
| FEI numbers | 2020726 |
| Establishment operations | 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