FDA device listing
Coronavirus Antigen Detection Test System.
FDA device listing 1196863456 · CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Key facts
| Owner/operator | CHEMBIO DIAGNOSTIC SYSTEMS, INC. |
|---|---|
| Owner/operator number | 2431980 |
| Product codes | QKP |
| Device names | QKP - Coronavirus Antigen Detection Test System. |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QKP |
| 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