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Nomenclature changes to part 864 appear at 73 FR 35341, June 23, 2008.
(a) Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.
(b) Classification. Class II (performance standards).
[45 FR 60620, Sept. 12, 1980]