{"data":{"id":"us/21-cfr-864.8540","jurisdiction":"us","citation":"21 CFR 864.8540","heading":"Red cell lysing reagent.","body":"(a) Identification. A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.\n(b) Classification. Class I (general controls). This device 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 I—Hematology 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":"d8254c28822e1f2fcb6ba17bb01345a9577a60679f1be934f28961145793a72c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.8500","next":"us/21-cfr-864.8625"},"notice":"GroundRules: Original legal text. Not legal advice."}