21 CFR 864.7060 — Antigen, Antiserum, Control, Antithrombin Iii
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7060
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DDQ | Antigen, Antiserum, Control, Antithrombin Iii | 2 | 4 | 3rd Party |
| JBQ | Antithrombin Iii Quantitation | 2 | 56 | 3rd Party |
| JPE | Antithrombin Iii, Two Stage Clotting Time Assay | 2 | 1 | 3rd Party |
