FDA device listing
QUANTA Lite GPA ELISA,QUANTA Lite GPA ELISA (Gastric Parietal Cell Antibody),QUANTA LIte GPA (Gastric Parietal Cell…
FDA device listing 1226865973 · INOVA DIAGNOSTICS, INC.
Key facts
| Proprietary names | QUANTA Lite GPA ELISA,QUANTA Lite GPA ELISA (Gastric Parietal Cell Antibody),QUANTA LIte GPA (Gastric Parietal Cell Antibody) ELISA |
|---|---|
| Owner/operator | INOVA DIAGNOSTICS, INC. |
| Owner/operator number | 2026994 |
| Premarket submissions | K010558 |
| Product codes | MLE |
| Device names | MLE - Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5110 |
| Review panels | Immunology |
| Registered establishments | INOVA DIAGNOSTICS, INC. |
| Establishment registrations | 2026994 |
| FEI numbers | 2026994 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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