QCU

Dengue Virus Antigen Assay

Product code: QCU
Device name: Dengue Virus Antigen Assay
Device class: Class 2
21 CFR: 21 CFR 866.3945
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QCU

Classification and pathway per current FDA publications. Data from openFDA (CC0).