Dengue Virus Antigen Assay

QCU · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3945

Classification

FDA Product Code: QCU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3945
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 1
Registered establishments: 8

Source

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