Title 21

SECTION 864.7875

864.7875 Thrombin time test.

§ 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]