CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART H—Hematology Kits and Packages (§864.7040 to §864.7925) > 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).

Code of Federal Regulations

[45 FR 60628, Sept. 12, 1980]