{"data":{"id":"us/21-cfr-864.5600","jurisdiction":"us","citation":"21 CFR 864.5600","heading":"Automated hematocrit instrument.","body":"(a) Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).\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 F—Automated and Semi-Automated Hematology Devices"],"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":"d6d27330bb04bc871c6e256e49d4eb3f302880a035d2beb06d4a5b694d701ffc","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.5430","next":"us/21-cfr-864.5620"},"notice":"GroundRules: Original legal text. Not legal advice."}