21 C.F.R. § 864.7735 Prothrombin-proconvertin test and thrombotest.
Title 21 - Food and Drugs
(a) Identification. The prothrombin-proconvertin test and thrombotest are devices used in the regulation of coumarin therapy (administration of a coumarin anticoagulant such as sodium warfarin in the treatment of venous thrombosis and pulmonary embolism) and as a diagnostic test in conjunction with, or in place of, the Quick prothrombin time test to detect coagulation disorders. (b) Classification. Class II (performance standards). [45 FR 60626, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7735 Prothrombin-proconvertin test and thrombotest.
