21 CFR § 864.7140
Activated whole blood clotting time tests
June 25, 2020
(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]
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