§ 864.7440 - Electrophoretic hemoglobin analysis system.

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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.

Classification. Class II (performance standards).