OZB

Dengue Nucleic Acid Amplification Assay (Naat)

Product code: OZB
Device name: Dengue Nucleic Acid Amplification Assay (Naat)
Device class: Class 2
21 CFR: 21 CFR 866.3946
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

A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).

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

Official FDA classification page: OZB

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