Code of Federal Regulations Title 21. Food and Drugs § 21.864.7100 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).