21 CFR § 866.3040 - spp. serological reagents.
---
identifier: "/us/cfr/t21/s866.3040"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3040 - spp. serological reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3040"
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"
---
# 866.3040 spp. serological reagents.
(a) *Identification. Aspergillus* spp. serological reagents are devices that consist of antigens and antisera used in various serological tests to identify antibodies to *Aspergillus* spp. in serum. The identification aids in the diagnosis of aspergillosis caused by fungi belonging to the genus *Aspergillus.* Aspergillosis is a disease marked by inflammatory granulomatous (tumor-like) lessions in the skin, ear, eyeball cavity, nasal sinuses, lungs, and occasionally the bones.
(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]