{"data":{"id":"us/21-cfr-866.5715","jurisdiction":"us","citation":"21 CFR 866.5715","heading":"Plasminogen immunological test system.","body":"(a) Identification. A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES","Subpart F—Immunological Test Systems"],"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":"d6a401efd01655a713e5ebdf078c54fec9520cad06bc958d422a55a52ce01c7d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5700","next":"us/21-cfr-866.5735"},"notice":"GroundRules: Original legal text. Not legal advice."}