Identification. Enzyme preparations are products that are used in the histopathology laboratory for the following purposes:
To disaggregate tissues and cells already in established cultures for preparation into subsequent cultures (e.g., trypsin);
To disaggregate fluid specimens for cytological examination (e.g., papain for gastric lavage or trypsin for sputum liquefaction);
To aid in the selective staining of tissue specimens (e.g., diastase for glycogen determination).
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.
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