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FDA PRODUCT CODE · CLASS II

PSZ — Devices Detecting Influenza A, B, And C Virus Antigens

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3328
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K252283Nano-Ditech Corporation · 510k2026-01-15
K250398Innovita (Tangshan) Biological Technology Co., Ltd. · 510k2025-07-03
K241188SEKISUI Diagnostics, LLC · 510k2025-04-18

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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