FDA device listing
AFIAS NORO
FDA device listing 1840284188 · Boditech Med Inc.
Key facts
| Proprietary names | AFIAS NORO |
|---|---|
| Owner/operator | Boditech Med Inc. |
| Owner/operator number | 10046783 |
| Product codes | OUC |
| Device names | OUC - Norovirus Serological Reagent |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3395 |
| Review panels | Microbiology |
| Registered establishments | BODITECH MED INC. |
| Establishment registrations | 3009491259 |
| FEI numbers | 3009491259 |
| 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