StacksVerified U.S. regulatory reference

21 CFR §864.7140

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II (performance standards).