FDA device listing
ADVIA Autoslide,Atellica HEMA Slidemaker Stainer Wright-Giemsa Buffer,Atellica HEMA Slidemaker Stainer Wright-Giemsa…
FDA device listing 1363177438 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | ADVIA Autoslide,Atellica HEMA Slidemaker Stainer Wright-Giemsa Buffer,Atellica HEMA Slidemaker Stainer Wright-Giemsa Stain,Hematek |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Product codes | HYF |
| Device names | HYF - Giemsa Stain |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1850 |
| Review panels | Hematology |
| Registered establishments | Siemens Healthcare Diagnostics Inc. |
| Establishment registrations | 2432235 |
| FEI numbers | 2432235 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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