§864.7875. Thrombin time test.
21 C.F.R. § 864.7875
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[45 FR 60628, Sept. 12, 1980]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60628, Sept. 12, 1980]