Dengue Nucleic Acid Amplification Assay (Naat)

OZB · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3946

Classification

FDA Product Code: OZB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3946
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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).

Market data

Cleared 510(k) submissions: 1
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown