ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
Device Facts
| Record ID | K935308 |
|---|---|
| Device Name | ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | JBQ · Hematology |
| Decision Date | May 17, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7060 |
| Device Class | Class 2 |
Regulatory Classification
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).
