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§ 864.7925 Partial thromboplastin time tests.

21 CFR 864.7925

Citation21 CFR 864.7925
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 864.7925 Partial thromboplastin time tests.

(a) Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

(b) Classification. Class II (performance standards).

[45 FR 60629, Sept. 12, 1980]