FDA device listing
COVID-19 total Ab Control LQ,FRCOA 020,FREND COVID-19 total Ab with the FREND System
FDA device listing 1758011481 · NanoEntek, Inc
Key facts
| Proprietary names | COVID-19 total Ab Control LQ,FRCOA 020,FREND COVID-19 total Ab with the FREND System |
|---|---|
| Owner/operator | NanoEntek, Inc |
| Owner/operator number | 10041714 |
| Product codes | QKO |
| Device names | QKO - Reagent, Coronavirus Serological |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QKO |
| Review panels | Microbiology |
| Registered establishments | NANOENTEK INC |
| Establishment registrations | 3007349751, 3009092698 |
| FEI numbers | 3007349751, 3009092698 |
| Establishment operations | Manufacturer, Specification Developer |
| 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