U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
Searching within:
All TitlesTitle 21Chapter IPart 864Subpart H - Subpart H—Hematology Kits and Packages
Exit search mode at current location
Exit search mode at current location
(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).
