21 C.F.R. § 864.7825
Sickle cell test.
Cite as 21 C.F.R. § 864.7825 (2026)
(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]