21 CFR § 866.2360 - Selective culture medium.

---
identifier: "/us/cfr/t21/s866.2360"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.2360 - Selective culture medium."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.2360"
section_name: "Selective culture medium."
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"
---


# 866.2360 Selective culture medium.

(a) *Identification.* A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

(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 the limitations in § 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 FR 38791, July 25, 2001]