{"data":{"id":"us/21-cfr-864.5680","jurisdiction":"us","citation":"21 CFR 864.5680","heading":"Automated heparin analyzer.","body":"(a) Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.\n(b) Classification. Class II (special controls).","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":"83552265d5d6b0cb6bcd1828026c20b1a022175b3e51ee76deaf1ea4d968efce","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.5620","next":"us/21-cfr-864.5700"},"notice":"GroundRules: Original legal text. Not legal advice."}