21 CFR 864.4400 — Heparin

Pathology (PA) · Part 864 Subpart E—Specimen Preparation Reagents · § 864.4400

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).

Classification Rationale

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.

Product Codes