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21 CFR 864.7875

§ 864.7875 Thrombin time test.

United States · 21 CFR — Food and Drugs · Status: effective

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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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(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.