21 C.F.R. § 864.7140
Activated whole blood clotting time tests.
Cite as 21 C.F.R. § 864.7140 (2026)
(a) Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood. (b) Classification. Class II (performance standards). [45 FR 60611, Sept. 12, 1980]