21 C.F.R. § 864.7720   Prothrombin consumption test.

Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages

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§ 864.7720   Prothrombin consumption test.

(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]

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