Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 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]
authority: 21 U.S.C. 351,360,360c,360e,360j,360
cite as: 21 CFR 864.7100