21 CFR § 866.3320 - serological reagents.

---
identifier: "/us/cfr/t21/s866.3320"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3320 - serological reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3320"
section_name: "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"
---


# 866.3320 serological reagents.

(a) *Identification. Histoplasma capsulatum* serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to *Histoplasma capsulatum* in serum. Additionally, some of these reagents consist of *Histoplasma capsulatum* antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify *Histoplasma capsulatum* from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of histoplasmosis caused by this fungus belonging to the genus *Histoplasma* and provides epidemiological information on the diseases caused by this fungus. Histoplasmosis usually is a mild and often asymptomatic respiratory infection, but in a small number of infected individuals the lesions may spread to practically all tissues and organs.

(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 59227, Nov. 3, 1998]