Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 864 - Hematology and Pathology Devices |
Subpart H - Hematology Kits and Packages |
§ 864.7100 - Red blood cell enzyme assay.
Latest version.
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§ 864.7100 Red blood cell enzyme assay.
(a) Identification. Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.
(b) Classification. Class II (performance standards).
[45 FR 60610, Sept. 12, 1980]