Code of Federal Regulations Title 21. Food and Drugs § 21.866.3945 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).