21 C.F.R. § 864.7825 Sickle cell test.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages
§ 864.7825 Sickle cell test.