21 C.F.R. § 864.7060

Current through September 30, 2024
Section 864.7060 - Antithrombin III assay
(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).

21 C.F.R. §864.7060

45 FR 60609, Sept. 12, 1980