GroundRules
21 CFR 864.4400: Enzyme preparations.
Where this section sits in the code
- 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
(a) Identification. Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:
(1) To disaggregate tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin);
(2) To disaggregate fluid specimens for cytological examination (e.g., papain for gastric lavage or trypsin for sputum liquefaction);
(3) To aid in the selective staining of tissue specimens (e.g., diastase for glycogen determination).
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON