FDA device listing
Progesterone AccuBind® ELISA Test System (Ref 4825-300A, 4825-300B),Progesterone AccuLite® CLIA Test System (Ref…
FDA device listing 1039014198 · MONOBIND, INC.
Key facts
| Proprietary names | Progesterone AccuBind® ELISA Test System (Ref 4825-300A, 4825-300B),Progesterone AccuLite® CLIA Test System (Ref 4875-300A, 4875-300B) |
|---|---|
| Owner/operator | MONOBIND, INC. |
| Owner/operator number | 2020726 |
| Product codes | JLS |
| Device names | JLS - Radioimmunoassay, Progesterone |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1620 |
| 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