FDA device listing
DPP® Dengue NS1 Antigen Assay
FDA device listing 1453912107 · CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Key facts
| Proprietary names | DPP® Dengue NS1 Antigen Assay |
|---|---|
| Owner/operator | CHEMBIO DIAGNOSTIC SYSTEMS, INC. |
| Owner/operator number | 2431980 |
| Product codes | OSU |
| Device names | OSU - Dengue Serological Reagents |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3945 |
| Review panels | Microbiology |
| Registered establishments | Chembio Diagnostic Systems, CHEMBIO DIAGNOSTIC SYSTEMS, INC. |
| Establishment registrations | 2431980, 3026565854 |
| FEI numbers | 2431980, 3026565854 |
| 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