21 CFR § 866.3085 - spp. serological reagents.

---
identifier: "/us/cfr/t21/s866.3085"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3085 - spp. serological reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3085"
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"
---


# 866.3085 spp. serological reagents.

(a) *Identification. Brucella* spp. serological reagents are devices that consist of antigens and antisera used for serological identification of *Brucella* spp. from cultured isolates derived from clinical specimens or to identify antibodies to *Brucella* spp. in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify *Brucella* spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of brucellosis (e.g., undulant fever, Malta fever) caused by bacteria belonging to the genus *Brucella* and provides epidemiological information on diseases caused by these microorganisms.

(b) *Classification.* Class II (special 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 63 FR 59226, Nov. 3, 1998]