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§ 864.7875 Thrombin time test.

21 CFR 864.7875

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  3. Title 21
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  9. Subpart H
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  11. 21 CFR 864.7875
Citation21 CFR 864.7875
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 864.7875 Thrombin time test.

(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).

[45 FR 60628, Sept. 12, 1980]