21 CFR 864.4400 - Enzyme preparations.

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§ 864.4400 Enzyme preparations.

(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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 13-Apr-2017 03:05

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 864 after this date.

  • 2016-03-01; vol. 81 # 40 - Tuesday, March 1, 2016
    1. 81 FR 10553 - Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments by May 31, 2016. Please see section IV of this document for the proposed effective date of a final rule that may issue based on this proposal.
      21 CFR Part 864