FDA device listing
PRL AccuBind® ELISA Test System (725-300A, 725-300B),PRL AccuLite® CLIA Test System (775-300A, 775-300B),PRLs AccuBind®…
FDA device listing 1807948426 · MONOBIND, INC.
Key facts
| Proprietary names | PRL AccuBind® ELISA Test System (725-300A, 725-300B),PRL AccuLite® CLIA Test System (775-300A, 775-300B),PRLs AccuBind® ELISA Test System (4425-300A, 4425-300B),PRLs AccuLite® CLIA Test System (4475-300A, 4475-300B) |
|---|---|
| Owner/operator | MONOBIND, INC. |
| Owner/operator number | 2020726 |
| Product codes | CFT |
| Device names | CFT - Radioimmunoassay, Prolactin (Lactogen) |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1625 |
| Review panels | Clinical Chemistry |
| Registered establishments | MONOBIND, INC. |
| Establishment registrations | 2020726 |
| FEI numbers | 2020726 |
| 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