Thrombin time test.
21 C.F.R. § 864.7875
in effectEffective: 2024-07-01(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).
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
