21 CFR § 864.7060 Hematology and Pathology Devices

§ 864.7060 Antithrombin III assay.

Current through Sep 8, 2026 · Read all of Part 864

(a) 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).

(b) Classification. Class II (performance standards).

[45 FR 60609, Sept. 12, 1980]

← § 864.7040 Adenosine triphosphate release assay.§ 864.7100 Red blood cell enzyme assay. →