FDA device listing
NIMBUS IVD, SEEGENE, 65415-02,NIMBUS IVD, SEEGENE, 65415-03,STARLET 8 AL ISWAP(LA),EXS (173000-EXS),STARLET IVD…
FDA device listing 1643257196 · HAMILTON CO.
Key facts
| Proprietary names | NIMBUS IVD, SEEGENE, 65415-02,NIMBUS IVD, SEEGENE, 65415-03,STARLET 8 AL ISWAP(LA),EXS (173000-EXS),STARLET IVD, SEEGENE, 67930-02,STARLET IVD, SEEGENE, 67930-03 |
|---|---|
| Owner/operator | HAMILTON CO. |
| Owner/operator number | 2915796 |
| Product codes | JQW |
| Device names | JQW - Station, Pipetting And Diluting, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2750 |
| Review panels | Clinical Chemistry |
| Registered establishments | HAMILTON CO. |
| Establishment registrations | 2915796 |
| FEI numbers | 2915796 |
| Establishment operations | Contract Manufacturer, 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