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Notes

§864.7100. Red blood cell enzyme assay.

21 C.F.R. § 864.7100

(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).
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]