{"data":{"id":"us/21-cfr-864.7440","jurisdiction":"us","citation":"21 CFR 864.7440","heading":"Electrophoretic hemoglobin analysis system.","body":"(a) Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.\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":"1e29b6654a21bd36c64cd7c450dc670f51f9337e2d43b04adeeacfe54b217178","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7425","next":"us/21-cfr-864.7455"},"notice":"GroundRules: Original legal text. Not legal advice."}