FDA device listing
PROFI BLOT 48,PROFI BLOT 48-2in1,PROFI BLOT T48
FDA device listing 1067120366 · Tecan Group AG
Key facts
| Proprietary names | PROFI BLOT 48,PROFI BLOT 48-2in1,PROFI BLOT T48 |
|---|---|
| Owner/operator | Tecan Group AG |
| Owner/operator number | 9050992 |
| Product codes | KPA |
| Device names | KPA - Slide Stainer, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3800 |
| Review panels | Pathology |
| Registered establishments | TECAN AUSTRIA GMBH, TECAN SCHWEIZ AG, Tecan Trading AG |
| Establishment registrations | 3002710220, 3003402518, 3003559191 |
| FEI numbers | 3002710220, 3003402518, 3003559191 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, 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