FDA device listing
TriniCLOT aPTT HS 10 ml,TriniCLOT aPTT HS 3 ml
FDA device listing 1366832029 · Diagnostica Stago, Inc.
Key facts
| Proprietary names | TriniCLOT aPTT HS 10 ml,TriniCLOT aPTT HS 3 ml |
|---|---|
| Owner/operator | Diagnostica Stago, Inc. |
| Owner/operator number | 9003476 |
| Premarket submissions | K881999 |
| Product codes | GIT |
| Device names | GIT - Reagent & Control, Partial Thromboplastin Time |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7925 |
| Review panels | Hematology |
| Registered establishments | DIAGNOSTICA STAGO, INC. |
| Establishment registrations | 2245451 |
| FEI numbers | 2245451 |
| Establishment operations | Complaint File Establishment |
| 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