{"data":{"id":"us/21-cfr-864.7415","jurisdiction":"us","citation":"21 CFR 864.7415","heading":"Abnormal hemoglobin assay.","body":"(a) Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.\n(b) Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart H—Hematology Kits and Packages"],"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":"682341854fdf620b4cb02cd2c3031aaece06003ba7cfd559d03ba4e974ef76aa","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7400","next":"us/21-cfr-864.7425"},"notice":"GroundRules: Original legal text. Not legal advice."}