{"data":{"id":"us/21-cfr-866.5590","jurisdiction":"us","citation":"21 CFR 866.5590","heading":"Lipoprotein X immunological test system.","body":"(a) Identification. A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease.\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":"2e7cdd2ebf1740700a869e5be4ed2f8464e41665a29b3ea177a3cf5355cbcd8b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5580","next":"us/21-cfr-866.5600"},"notice":"GroundRules: Original legal text. Not legal advice."}