21 C.F.R. · Food and Drugs
21 C.F.R. § 864.7750

Prothrombin time test.

Title 21 C.F.R. ● ACTIVE Primary Source
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21 C.F.R. § 864.7750 — Prothrombin time test.

§ 864.7750 Prothrombin time test. (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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21 C.F.R. § 864.7750
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The regulatory text of 21 C.F.R. § 864.7750 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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