{"data":{"id":"us/21-cfr-864.7275","jurisdiction":"us","citation":"21 CFR 864.7275","heading":"Euglobulin lysis time tests.","body":"(a) Identification. A euglobulin lysis time test is a device that measures the length of time required for the lysis (dissolution) of a clot formed from fibrinogen in the euglobulin fraction (that fraction of the plasma responsible for the formation of plasmin, a clot lysing enzyme). This test evaluates natural fibrinolysis (destruction of a blood clot after bleeding has been arrested). The test also will detect accelerated fibrinolysis.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.","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":"de46e2f4ebf3abccfff996dd6386c44552d7fe4e506855059d0aadbf6fa7b412","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7250","next":"us/21-cfr-864.7280"},"notice":"GroundRules: Original legal text. Not legal advice."}