Product code OZB

Device name

Dengue Nucleic Acid Amplification Assay (Naat)

Medical specialty

Microbiology

Device class

2

Regulation number

866.3946

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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).

Source

FDA openFDA device classification dataset