FDA device listing
AT-2000F Fluorescence AFB Auto Stainer,AT-2000G GRAM Auto Stainer,AT-2000H HEMA(MGG or WR) Auto Stainer,AT-2000K Kinyoun…
FDA device listing 1285788752 · DAGATRONICS CORPORATION
Key facts
| Proprietary names | AT-2000F Fluorescence AFB Auto Stainer,AT-2000G GRAM Auto Stainer,AT-2000H HEMA(MGG or WR) Auto Stainer,AT-2000K Kinyoun AFB Auto Stainer,AT-2000Z Ziehl-Neelsen AFB Auto Stainer,AT-3001 AFB Multi Stainer,AT-3002 GRAM/AFB(Z/N) Dual Stainer,AT-3003 GRAM/AFB(F/L) Dual Stainer,AT-3004 GRAM/HEMA(MGG) Dual Stainer,DAGATRON AT-1000,DAGATRON DX-300 |
|---|---|
| Owner/operator | DAGATRONICS CORPORATION |
| Owner/operator number | 10049067 |
| Product codes | KPA |
| Device names | KPA - Slide Stainer, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3800 |
| Review panels | Pathology |
| Registered establishments | DAGATRONICS CORPORATION |
| Establishment registrations | 3009596884 |
| FEI numbers | 3009596884 |
| Establishment operations | 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