FDA device listing
QUANTA Flash DFS70 Calibrators,QUANTA Flash HMGCR Calibrators,QUANTA Flash Intrinsic Factor Calibrators,QUANTA Flash RF…
FDA device listing 1584262473 · INOVA DIAGNOSTICS, INC.
Key facts
| Proprietary names | QUANTA Flash DFS70 Calibrators,QUANTA Flash HMGCR Calibrators,QUANTA Flash Intrinsic Factor Calibrators,QUANTA Flash RF IgA Calibrators,QUANTA Flash RF IgM Calibrators,QUANTA Flash Ribosomal P Calibrators |
|---|---|
| Owner/operator | INOVA DIAGNOSTICS, INC. |
| Owner/operator number | 2026994 |
| Product codes | JIT |
| Device names | JIT - Calibrator, Secondary |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150 |
| Review panels | Clinical Chemistry |
| 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
- 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