§ 864.7720. Prothrombin consumption test.
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/us/cfr/t21/s§ 864.7720·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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 (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. [45 FR 60625, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]