21 CFR 864.7875
§ 864.7875 Thrombin time test.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7875, § 864.7875 Thrombin time test, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89391
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Full text
(a) Identification. A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.
(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.