contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.