FDA device listing
Tissue-Tek Prisma® H&E Stain Kit #1,Tissue-Tek Prisma® H&E Stain Kit #2
FDA device listing 1702307108 · Sakura Global Holding Company
Key facts
| Proprietary names | Tissue-Tek Prisma® H&E Stain Kit #1,Tissue-Tek Prisma® H&E Stain Kit #2 |
|---|---|
| Owner/operator | Sakura Global Holding Company |
| Owner/operator number | 8031662 |
| Product codes | HZT |
| Device names | HZT - Reagent, Schiff |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.1850 |
| Review panels | Hematology |
| Registered establishments | SAKURA FINETEK U.S.A., INC. |
| Establishment registrations | 2083544 |
| FEI numbers | 2083544 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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