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Code · CFR · Title 21 — Food and Drugs · Part 864 — Hematology and Pathology Devices · § 864.7750

§ 864.7750. Prothrombin time test.

74 words·~1 min read·/us/cfr/t21/s§ 864.7750·

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(a)Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
(b)Classification. Class II (performance standards). [45 FR 60626, Sept. 12, 1980]
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