Pure Global
FDA product code QCU

Dengue Virus Antigen Assay

Microbiology·Class 2·21 CFR 866.3945
US regulatory classifications
US Product Code (FDA)
QCU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3945
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
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

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About this record

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.