21 CFR § 864.2280 - Cultured animal and human cells.
---
identifier: "/us/cfr/t21/s864.2280"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.2280 - Cultured animal and human cells."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.2280"
section_name: "Cultured animal and human cells."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---
# 864.2280 Cultured animal and human cells.
(a) *Identification.* Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.
(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
[45 FR 60585, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]