StacksVerified U.S. regulatory reference

21 CFR §864.7825

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (performance standards).