§ 864.7060. Antithrombin III assay.
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/us/cfr/t21/s§ 864.7060·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]