DDQ · Antigen, Antiserum, Control, Antithrombin Iii
Hematology · 21 CFR 864.7060 · Class 2
Overview
| Product Code | DDQ |
|---|---|
| Device Name | Antigen, Antiserum, Control, Antithrombin Iii |
| Regulation | 21 CFR 864.7060 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | Crestat Diagnostics, Inc. | Oct 20, 1997 | SESE |
| K935307 | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA | Baxter Diagnostics, Inc. | Nov 22, 1994 | SESE |
| K932713 | TRACE TRANSFERRIN REAGENT | Trace Scientific , Ltd. | Sep 30, 1993 | SESE |
| K780012 | ANTITHROMBIN III RIA | Ria Diagnostics | Jan 20, 1978 | SESE |
Top Applicants
- Baxter Diagnostics, Inc. — 1 clearance
- Crestat Diagnostics, Inc. — 1 clearance
- Ria Diagnostics — 1 clearance
- Trace Scientific , Ltd. — 1 clearance
