§ 864.7440. Electrophoretic hemoglobin analysis system.
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/us/cfr/t21/s§ 864.7440·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]