21 CFR § 866.3355 - spp. serological reagents.

---
identifier: "/us/cfr/t21/s866.3355"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3355 - spp. serological reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3355"
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"
---


# 866.3355 spp. serological reagents.

(a) *Identification. Listeria* spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify *Listeria* spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of *Listeria* spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify *Listeria* spp. directly from clinical specimens. The identification aids in the diagnosis of listeriosis, a disease caused by bacteria belonging to the genus *Listeria,* and provides epidemiological information on diseases caused by these microorganisms. *Listeria monocytogenes,* the most common human pathogen of this genus, causes meningitis (inflammation of the brain membranes) and meningoencephalitis (inflammation of the brain and brain membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauterine infection in pregnant women that results in a high mortality rate for infants before or after birth.

(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]