21 CFR 864.7750
§ 864.7750 Prothrombin time test.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7750, § 864.7750 Prothrombin time test, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89389
- Permanent ID
ys:prov:89389@1- SHA-256
201c7a5ed141d5042b6035a1a0dc3403255b567cc04ffa0ca067c8c2024e989d
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.