FDA device listing
AssayTip/AssayCup tray,Assay Tip / Cup Elecsys Modular DS,C4800 AD-plate 0.3ml,LIAISON XL Cuvettes (X0016)
FDA device listing 1058778094 · Balda Medical GmbH
Key facts
| Proprietary names | AssayTip/AssayCup tray,Assay Tip / Cup Elecsys Modular DS,C4800 AD-plate 0.3ml,LIAISON XL Cuvettes (X0016) |
|---|---|
| Owner/operator | Balda Medical GmbH |
| Owner/operator number | 10030599 |
| Product codes | LXG |
| Device names | LXG - Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2050 |
| Review panels | Clinical Chemistry |
| Registered establishments | BALDA MEDICAL GmbH |
| Establishment registrations | 3007963752 |
| FEI numbers | 3007963752 |
| Establishment operations | Contract 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