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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 864 - Hematology and Pathology Devices |
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Subpart H - Hematology Kits and Packages |
§ 864.7735 - Prothrombin-proconvertin test and thrombotest.
Latest version.
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§ 864.7735 Prothrombin-proconvertin test and thrombotest.
(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). 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 60626, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]