{"data":{"id":"us/21-cfr-864.7825","jurisdiction":"us","citation":"21 CFR 864.7825","heading":"Sickle cell test.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart H—Hematology Kits and Packages"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"492a3f553c6a633ca75707e3c8131bb4214511edc508dd3ed4ae901902c6817a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7750","next":"us/21-cfr-864.7875"},"notice":"GroundRules: Original legal text. Not legal advice."}