Electrophoretic hemoglobin analysis system.

21 C.F.R. § 864.7440
in effectEffective: 2024-07-01
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(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).

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