21 CFR 864.7875 - Thrombin time test.
Code of Federal Regulations - Title 21: Food and Drugs (December 2005)
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TITLE 21 - FOOD AND DRUGS
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
subpart h - HEMATOLOGY KITS AND PACKAGES
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]
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