FDA device listing
Microorganism Identification Biochip
FDA device listing 1710049731 · Novascope Diagnostics Inc.
Key facts
| Proprietary names | Microorganism Identification Biochip |
|---|---|
| Owner/operator | Novascope Diagnostics Inc. |
| Owner/operator number | 10094402 |
| Product codes | LIB |
| Device names | LIB - Device, General Purpose, Microbiology, Diagnostic |
| Device class | Class I |
| Classification regulations (21 CFR) | 866.2660 |
| Review panels | Microbiology |
| Registered establishments | NOVASCOPE DIAGNOSTICS INC. |
| Establishment registrations | 3042159574 |
| FEI numbers | 3042159574 |
| Establishment operations | Foreign Exporter, Foreign Private Label Distributor, 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