FDA device listing
QUANTA Lite ENA 4,QUANTA Lite ENA 4 ELISA,QUANTA Lite ENA 4 ELISA Sm,RNP, SS-A and SS-B Screening Test
FDA device listing 2036680537 · Instrumentation Laboratory SpA
Key facts
| Proprietary names | QUANTA Lite ENA 4,QUANTA Lite ENA 4 ELISA,QUANTA Lite ENA 4 ELISA Sm,RNP, SS-A and SS-B Screening Test |
|---|---|
| Owner/operator | Instrumentation Laboratory SpA |
| Owner/operator number | 10082968 |
| Premarket submissions | K922829 |
| Product codes | LLL |
| Device names | LLL - Extractable Antinuclear Antibody, Antigen And Control |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5100 |
| Review panels | Immunology |
| Registered establishments | INSTRUMENTATION LABORATORY SPA |
| Establishment registrations | 3012348571 |
| FEI numbers | 3012348571 |
| Establishment operations | Foreign Exporter |
| 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