Title 21

SECTION 864.7440

864.7440 Electrophoretic hemoglobin analysis system.

§ 864.7440 Electrophoretic hemoglobin analysis system.

(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]

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