FDA device listing
CA 15-3 AccuBind® ELISA Test System (Ref 5625-300A and 5625-300B),CA 15-3 AccuLite® CLIA Test System (Ref 5675-300A and…
FDA device listing 2066496993 · MONOBIND, INC.
Key facts
| Proprietary names | CA 15-3 AccuBind® ELISA Test System (Ref 5625-300A and 5625-300B),CA 15-3 AccuLite® CLIA Test System (Ref 5675-300A and 5675-300B) |
|---|---|
| Owner/operator | MONOBIND, INC. |
| Owner/operator number | 2020726 |
| Product codes | MOI |
| Device names | MOI - System, Test, Immunological, Antigen, Tumor |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.6010 |
| Review panels | Immunology |
| 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