21 CFR § 866.2660 - Microorganism differentiation and identification device.
---
identifier: "/us/cfr/t21/s866.2660"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.2660 - Microorganism differentiation and identification device."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.2660"
section_name: "Microorganism differentiation and identification device."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY 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."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---
# 866.2660 Microorganism differentiation and identification device.
(a) *Identification.* A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
(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 § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]