{"data":{"id":"us/21-cfr-864.4400","jurisdiction":"us","citation":"21 CFR 864.4400","heading":"Enzyme preparations.","body":"(a) Identification. Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:\n(1) To disaggregate tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin);\n(2) To disaggregate fluid specimens for cytological examination (e.g., papain for gastric lavage or trypsin for sputum liquefaction);\n(3) To aid in the selective staining of tissue specimens (e.g., diastase for glycogen determination).\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 E—Specimen Preparation 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":"f98c77af61bed540e5bd5a4992fe310f0fa6d6a2cbee36ac5e997aaa6d0e58cd","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.4020","next":"us/21-cfr-864.5200"},"notice":"GroundRules: Original legal text. Not legal advice."}