U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
Searching within:
All TitlesTitle 21Chapter IPart 864Subpart H - Subpart H—Hematology Kits and Packages
Exit search mode at current location
Exit search mode at current location
(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).
