21 C.F.R. § 864.7875

Thrombin time test.

Last amended: 2016Year: 2026Length: 39 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 864.7875 (2026)

(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]
21 C.F.R. § 864.7875: Thrombin time test. | Justis AI