864.7100 Red blood cell enzyme assay.§ 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]