21 CFR § 866.3945 - Dengue virus serological reagents.

---
identifier: "/us/cfr/t21/s866.3945"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.3945 - Dengue virus serological reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.3945"
section_name: "Dengue virus 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"
---


# 866.3945 Dengue virus serological reagents.

(a) *Identification.* Dengue virus serological reagents are devices that consist of antigens and antibodies for the detection of dengue virus and dengue antibodies in individuals who have signs and symptoms of dengue fever or dengue hemorrhagic fever. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus.

(b) *Classification.* Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Dengue Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).

[79 FR 31023, May 30, 2014]