21 CFR § 866.3200 - spp. serological reagents.

---
identifier: "/us/cfr/t21/s866.3200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3200 - spp. serological reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3200"
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"
---


# 866.3200 spp. serological reagents.

(a) *Identification. Echinococcus* spp. serological reagents are devices that consist of *Echinococcus* spp. antigens and antisera used in serological tests to identify antibodies to *Echinococcus* spp. in serum. The identification aids in the diagnosis of echinococcosis, caused by parasitic tapeworms belonging to the genus *Echinococcus* and provides epidemiological information on this disease. Echinococcosis is characterized by the development of cysts in the liver, lung, kidneys, and other organs formed by the larva of the infecting organisms.

(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]