FDA device listing
Siemens Healthcare Diagnostics Inc.
FDA device listing 1224480398 · BIT Analytical Solutions GmbH
Key facts
| Proprietary names | Siemens Healthcare Diagnostics Inc. |
|---|---|
| Owner/operator | BIT Analytical Solutions GmbH |
| Owner/operator number | 9072503 |
| Product codes | KPA |
| Device names | KPA - Slide Stainer, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3800 |
| Review panels | Pathology |
| Registered establishments | BIT Analytical Solutions GmbH |
| Establishment registrations | 3003601075 |
| FEI numbers | 3003601075 |
| 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