21 C.F.R. § 864.7720 Prothrombin consumption test.
Title 21 - Food and Drugs
(a) Identification. A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B. (b) Classification. Class II (performance standards). [45 FR 60625, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7720 Prothrombin consumption test.
