CFR
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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.
Code of Federal Regulations
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