{"data":{"id":"us/21-cfr-866.5820","jurisdiction":"us","citation":"21 CFR 866.5820","heading":"Systemic lupus erythematosus immunological test system.","body":"(a) Identification. A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).\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 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":"2a8250d603144c5a5bb55769fbd8eb7125123ef5eea5b869e3e0b1ef2ff59969","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5800","next":"us/21-cfr-866.5830"},"notice":"GroundRules: Original legal text. Not legal advice."}