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Dengue Virus Antigen Assay

Dengue Virus Antigen Assay is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Dengue Virus Antigen Assay
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QCU

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Class 2

21 CFR 866.3945

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Microbiology

Device Characteristics

No

No

No

Not Eligible

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