FDA device listing
Anti-CCP IgG AccuBind® ELISA Test System (Refs 12725-300A 12725-300B),Anti-CCP IgG AccuLite® CLIA Test System (Refs…
FDA device listing 1442642539 · MONOBIND, INC.
Key facts
| Proprietary names | Anti-CCP IgG AccuBind® ELISA Test System (Refs 12725-300A 12725-300B),Anti-CCP IgG AccuLite® CLIA Test System (Refs 12775-300A 12775-300B) |
|---|---|
| Owner/operator | MONOBIND, INC. |
| Owner/operator number | 2020726 |
| Product codes | NHX |
| Device names | NHX - Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5775 |
| 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