SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
Device Facts
| Record ID | K960871 |
|---|---|
| Device Name | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) |
| Applicant | Medical Diagnostic Technologies, Inc. |
| Product Code | JBQ · Hematology |
| Decision Date | Aug 14, 1996 |
| 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).
