21 CFR § 866.3140 - spp. serological reagents.

---
identifier: "/us/cfr/t21/s866.3140"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3140 - spp. serological reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3140"
section_name: "spp. serological reagents."
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"
---


# 866.3140 spp. serological reagents.

(a) *Identification. Corynebacterium* spp. serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify *Corynebacterium* spp. from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus *Corynebacterium* and provides epidemiological information on diseases caused by these microorganisms. The principal human pathogen of this genus, *Corynebacterium diphtheriae,* causes diphtheria. However, many other types of corynebacteria form part of the normal flora of the human respiratory tract, other mucus membranes, and skin, and are either nonpathogenic or have an uncertain role.

(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]