{"data":{"id":"us/21-cfr-866.5230","jurisdiction":"us","citation":"21 CFR 866.5230","heading":"Colostrum immunological test system.","body":"(a) Identification. A colostrum immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific proteins in colostrum. Colostrum is a substance excreted by the mammary glands during pregnancy and until production of breast milk begins 1 to 5 days after childbirth.\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 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":"0f0ac5264c3f6b83f6082af7fce5cf88f2bdcc7f844d92750dd7fec27576ff48","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-866.5220","next":"us/21-cfr-866.5240"},"notice":"GroundRules: Original legal text. Not legal advice."}