{"data":{"id":"us/21-cfr-864.7100","jurisdiction":"us","citation":"21 CFR 864.7100","heading":"Red blood cell enzyme assay.","body":"(a) Identification. Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.\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":"f827649aa901f61f643ea192fcf26b13725b6e9797a98bbc0a1f7d3a828a7d0e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7060","next":"us/21-cfr-864.7140"},"notice":"GroundRules: Original legal text. Not legal advice."}