FDA device listing
Technozym ADAMTS13 Activity
FDA device listing 1918566004 · Technoclone Herstellung v. Diagnostika u. Arzneimitteln GmbH
Key facts
| Proprietary names | Technozym ADAMTS13 Activity |
|---|---|
| Owner/operator | Technoclone Herstellung v. Diagnostika u. Arzneimitteln GmbH |
| Owner/operator number | 10031758 |
| Premarket submissions | DEN230024 |
| Product codes | SAC |
| Device names | SAC - Adamts13 Activity Test System |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7297 |
| Review panels | Hematology |
| Registered establishments | TECHNOCLONE |
| Establishment registrations | 3003453957 |
| FEI numbers | 3003453957 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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