21 CFR § 866.2410 - Culture medium for pathogenic spp.

---
identifier: "/us/cfr/t21/s866.2410"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.2410 - Culture medium for pathogenic  spp."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.2410"
section_name: "Culture medium for pathogenic  spp."
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"
---


# 866.2410 Culture medium for pathogenic  spp.

(a) *Identification.* A culture medium for pathogenic *Neisseria* spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenic *Neisseria* spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus *Neisseria,* such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.

(b) *Classification.* Class II (performance standards).