864.7825 Sickle cell test.§ 864.7825 Sickle cell test.
(a) Identification. A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.
(b) Classification. Class II (performance standards).[45 FR 60627, Sept. 12, 1980]