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Devices Detecting Influenza A, B, And C Virus Antigens

Devices Detecting Influenza A, B, And C Virus Antigens 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
Devices Detecting Influenza A, B, And C Virus Antigens
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PSZ

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Class 2

21 CFR 866.3328

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Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.