StacksVerified U.S. regulatory reference

21 CFR §864.7875

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (performance standards).