PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY
Device Facts
| Record ID | K770942 |
|---|---|
| Device Name | PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY |
| Applicant | Pharmaseal Div., Baxter Healthcare Corp. |
| Product Code | JBQ · Hematology |
| Decision Date | Jul 21, 1977 |
| 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).
