21 CFR 864.8500

§ 864.8500 Lymphocyte separation medium.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 864.8500, § 864.8500 Lymphocyte separation medium, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89401
Permanent ID: ys:prov:89401@1
SHA-256: 946d50b57458d9af504faf2f2448d9aa56c95e8a676029b59a07f74820df5aa3

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(a) Identification. A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood. (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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.