Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart H - Hematology Kits and Packages / § 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).