FDA product code PSZ

Devices Detecting Influenza A, B, And C Virus Antigens

Microbiology·Class 2·21 CFR 866.3328
US regulatory classifications
US Product Code (FDA)
PSZ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3328
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
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.

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About this record

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.