§ 864.4400. Enzyme preparations.
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/us/cfr/t21/s§ 864.4400·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38789, July 25, 2001]