{"data":{"id":"us/21-cfr-864.7525","jurisdiction":"us","citation":"21 CFR 864.7525","heading":"Heparin assay.","body":"(a) Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).\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":"515ca31e1b09a5ffc69525eca6f1a05b47d4fe2e8b3792cd7b3d87bef58380ae","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7500","next":"us/21-cfr-864.7660"},"notice":"GroundRules: Original legal text. Not legal advice."}