{"data":{"id":"us/21-cfr-866.4830","jurisdiction":"us","citation":"21 CFR 866.4830","heading":"Rocket immunoelectrophoresis equipment.","body":"(a) Identification. Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height of the peak (or the area under the peak) is proportional to the concentration of the protein.\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 the limitations in § 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 E—Immunology Laboratory Equipment and Reagents"],"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":"f9c2679a7e10695db85b3e461616fc63df3958e12f7eb5fd75978a713018af19","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.4800","next":"us/21-cfr-866.4900"},"notice":"GroundRules: Original legal text. Not legal advice."}