§864.4400. Enzyme preparations.
21 C.F.R. § 864.4400
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.
Notes, amendments, and revision history
Amendments
[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38789, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60592, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38789, July 25, 2001]