21 CFR § 864.7140 Hematology and Pathology Devices

§ 864.7140 Activated whole blood clotting time tests.

Current through Sep 8, 2026 · Read all of Part 864

(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]

← § 864.7100 Red blood cell enzyme assay.§ 864.7250 Erythropoietin assay. →