§864.7100. Red blood cell enzyme assay.
21 C.F.R. § 864.7100
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[45 FR 60610, Sept. 12, 1980]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60610, Sept. 12, 1980]