DDQ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigen, Antiserum, Control, Antithrombin Iii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7060
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| N-ASSAY TIA ANTITHROMBIN III TEST KIT (K972257) | Crestat Diagnostics, Inc. | 1997-10-20 |
| DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA (K935307) | Baxter Diagnostics, Inc. | 1994-11-22 |
| TRACE TRANSFERRIN REAGENT (K932713) | Trace Scientific , Ltd. | 1993-09-30 |
| ANTITHROMBIN III RIA (K780012) | Ria Diagnostics | 1978-01-20 |
Track DDQ automatically
Every clearance here is in the API, with alerts when new ones post.