21 C.F.R. § 864.7440

Current through September 30, 2024
Section 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).

21 C.F.R. §864.7440

45 FR 60620, Sept. 12, 1980