FDA device listing
610208 revogene MOCK PIE,revogene MOCK PIE
FDA device listing 1508750150 · MERIDIAN BIOSCIENCE, INC.
Key facts
| Proprietary names | 610208 revogene MOCK PIE,revogene MOCK PIE |
|---|---|
| Owner/operator | MERIDIAN BIOSCIENCE, INC. |
| Owner/operator number | 1524213 |
| Product codes | OOI |
| Device names | OOI - Real Time Nucleic Acid Amplification System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570 |
| Review panels | Clinical Chemistry |
| Registered establishments | MERIDIAN BIOSCIENCE, INC. |
| Establishment registrations | 1524213 |
| FEI numbers | 1524213 |
| 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