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§ 864.7750 Prothrombin time test.

21 CFR 864.7750

Citation21 CFR 864.7750
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 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]