FDA device listing
QUANTA Flash Ro60 Calibrators,QUANTA Flash Ro60 Controls,QUANTA Flash Ro60 Reagents
FDA device listing 1323235282 · Instrumentation Laboratory SpA
Key facts
| Proprietary names | QUANTA Flash Ro60 Calibrators,QUANTA Flash Ro60 Controls,QUANTA Flash Ro60 Reagents |
|---|---|
| Owner/operator | Instrumentation Laboratory SpA |
| Owner/operator number | 10082968 |
| Premarket submissions | K141328 |
| Product codes | JIT, JJX, LLL |
| Device names | JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), LLL - Extractable Antinuclear Antibody, Antigen And Control |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 866.5100 |
| Review panels | Clinical Chemistry, 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
- 1–9 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